Starting from 1 January 2022, the summary includes some safety alerts related to medical devices not listed under MDACS reported by the trade, other regulatory jurisdictions as well as the World Health Organization. It only serves as a reference and should not be considered as exhaustive and up-to-date information. Please contact manufacturer or local supplier for details.
| Posting Date | Description of Product | Source of Information * |
|---|---|---|
| 05 Apr 2024 | Product Defect Correction: Fanttest COVID-19 / Influenza A&B Antigen Test Kit - Potential for control line variability | TGA |
| 18 Mar 2024 | Hangzhou Fanttest Biotech Co Ltd (Sponsored by Australia Health Products Central Pty Ltd) Fanttest COVID-19/lnfluenza A&B Antigen Test Kit | TGA |
| 22 Feb 2024 | Sonictec Pty Ltd Fanttest COVID-19/Influenza A&B Antigen Test Kit [Product Identifiers: I2210004 to I2210006, I2212002 to I2212006 and all batches after; Expiry Date: 09/2023 to 05/2025] | TGA |
| 16 Feb 2024 | Quidel Corporation Sofia 2 Flu + SARS Antigen FIA [UDI-DI: 30014613339229; Lot number : 709083] | FDA |
| 25 Jan 2024 | Hologic, Inc. PANTHER FUSION System REF 912101000 | FDA |
| 19 Jan 2024 | PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID COVID-19 Rapid Antigen At-Home Test [REF: P0040; Lot: 22S0388-R01] | FDA |
| 23 Nov 2023 | Cepheid Xpert Xpress CoV-2/Flu/RSV plus [Single Registration Number (SRN): US-MF-000010979; Unique Device Part Number Identifier (UDI): 07332940008000; Part Number: XP3COV2/FLU/RSV-10; All batch number, lot number] | MHRA |
| 21 Nov 2023 | Abbott Rapid Diagnostics Pty Ltd ID NOW Instrument. An in vitro diagnostic medical device (IVD) [Part Number: NAT-000, NAT-000S; All serial numbers] | TGA |
| 17 Nov 2023 | Pulse Oximeter Accuracy and Limitations: FDA Safety Communication | FDA |
| 25 Sep 2023 | Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022 | FDA |
| 24 Jul 2023 | Qiagen GmbH QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD [REF 691223; GTIN: 14053228038846 LOT Number: 175010712; Affected Serial numbers (SNs) are from 330559516 to 330559783] | FDA |
| 07 Jul 2023 | NeuMoDx Molecular Inc NeuMoDx SARS-CoV-2 Assay - IVD [Lot Number: 123909 Exp. Date: 08-Dec-2023] | FDA |
| 07 Jun 2023 | QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691214, GTIN 14053228038877 [Lots: 172043034, 172043348, 172043349, 172043369, 172044712, 172046775, 172048091, 172048381, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669] | MHRA |
| 06 Jun 2023 | Becton Dickinson & Co. BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B [Catalog Number: 256088; Multiple lot numbers] | FDA |
| 06 Jun 2023 | Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test [Reference Number: 691223] | FDA |
| 31 May 2023 | ALLTEST Covid-19 Antigen Rapid Test (Oral Fluid) [ICOV-802H] and ALLTEST SARS-CoV-2 Antigen Rapid Test (Nasal Swab) [INCP-502H] | DH |
| 05 May 2023 | SD Biosensor, Inc. Pilot COVID-19 At-Home Tests | FDA |
| 10 Feb 2023 | Diasorin Molecular LLC Simplexa Covid-19 Direct [Model or Catalog Number: MOL4150; Lot or Serial Number: 13967N, 13968N, 15061N, 13330N, 13331N, 14016N, 13336N] | Health Canada |
| 10 Feb 2023 | Diasorin Molecular LLC Simplexa Covid-19 & Flu A/B Direct [Model or Catalogue Number: MOL4250; Lot or Serial Number: 15058N, 15951N] | Health Canada |
| 30 Jan 2023 | Universal Meditech Inc. 1) Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT; 2) SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING [Model Number: 550-10 UDI Code: None Lot Numbers: UL-AG-2111-01-Q UL-AG-2111-02-Q UL-AG-2110-05-Q UL-AG-2112-02-Q UL-AG-2110-03-Q UL-AG-2110-04-Q] | FDA |
| 13 Dec 2022 | Detect, Inc. Detect Covid-19 Test [Lot Numbers: HB264, HY263, HY264] | FDA |
| 09 Dec 2022 | Dewei Medical Equipment Co. Dewei Medical Equipment Co. DNA/RNA Preservation Kits [Product Catalog Number: DW-80005-1B; Distribution Dates: May 2020 to January 2022] | FDA |
| 01 Dec 2022 | GS Biomark LLC CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers / Lot Numbers: BC-DK0200 / 42821005 BM-AD4K0200 / 110421005, 110121005, 62322004 BM-ADK0200 / 110121003 BM-CDK0200 / 110121004 BM-CFDK0200 / 110121006 BM-D4K0200 / 71221003, 72021004, 81021003, 92721002, 102521003, 112221002, 30122001 BM-DK0200 / 51821001, 71221002, 72021003, 72721001, 80521001, 80921003, 81021002, 90721003, 90721004, 90921003, 90921003, 90921003, 102521002, 111521002, 22422002 BM-DK0600 / 110521002, 10722003, 12122004 BM-DK0800 / 12722006 BM-DK1200 / 120221002, 50222002 BM-DK1400 / 92421002, 101821005, 32222004 BM-DK1800 / 92321001, 92421001, 101821004, 110521001, 112321001, 120221001, 10722002, 12122002, 12722005, 32222003, 50222001, 60622001, 62922001 | FDA |
| 28 Oct 2022 | LumiraDx LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit [Catalog #: L016080109002 (EUA); LQC Kit: 2002204017; Positive Control Vial: 1000 1710 0014 0141; Negative Control Vial: 1000 1720 0014 0142; Exp. Date: 01-Mar-2023] | FDA |
| 19 Oct 2022 | American Contract Systems, Inc. COVID Test Kit Nonsterile [1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)] | FDA |
| 19 Oct 2022 | LUMINOSTICS, INC dba CLIP HEALTH Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 [Lots: CC-10094-A, CC-10115-A, CC-10123-A, CC-10129-A, CC-10136-A, CC-10144-A, CC-10148-A, CC-10166-A, CC-10168-A, CC-10168-B, CC-10189-A, CC-10193-A, CC-10300-A, CC-10328-A, CC-10329-A, CC-10330-A, CC-10361-A, CC-10364-A, CC-10365-A, CC-10368-A, CC-10369-A, CC-10395-A, CC-10396-A, CC-10397-A, CC-10398-A, CC-10399-A, CC-10439-A, CC-10440-A, CC-10440-B, CC-10441-A, CC-10441-B, CC-10609-A, CC-10609-B, CC-10611-A, CC-10613-A, CC-10615-A, CC-10654-A, CC-10667-A, CC-10710-A, CC-10710-B, CC-10712-A, CC-10714-A, CC-10714-B, CC-10725-A, CC-10727-A, CC-10729-A, CC-10766-A, CC-10768-A, CC-10809-S, CC-10811-S, CC-10874-A, CC-10874-B, CC-10874-C, CC-50002-S, CC-50003-S, CC-50004-S Expiration Dates: expiry.clipcovid.com] | FDA |
| 13 Oct 2022 | Jiangsu Well Biotech Co., Ltd COVID-19 Ag Rapid Test Devices | FDA |
| 05 Oct 2022 | Thermo Fisher Scientific Amplitude Platform with TaqPath COVID-19 HT Kit [Catalog #A50883] | MHRA |
| 30 Sep 2022 | Luminex Corporation ARIES SARS-CoV-2 Assay [Part No.: 50-10047; Lot Number (Expiry Date): AB4723A (05/25/2022); AB5041A (05/25/2022); AB5060A (06/01/2022); AB5061A (06/06/2022); AB5081A (06/07/2022); AB5139A (09/10/2022); AB5141A (09/16/2022); AB5263A (09/27/2022); AB5282A (10/05/2022)] | Firm |
| 14 Sep 2022 | Abbott Molecular, Inc. Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use. [Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085] | FDA |
| 25 Aug 2022 | Assure Tech. Co. Ltd. Ecotest Covid-19 Antigen Rapid Test Device [model/catalogue: COV-S23002; Lot/serial: I2201505] | Health Canada |
| 24 Aug 2022 | Luminex Corporation ARIES SARS-CoV-2 Assay [Lot: AB4042A] | FDA |
| 12 Aug 2022 | At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication | FDA |
| 10 Aug 2022 | Haimen Shengbang Laboratory Equipment Co. Ltd Viral Transport Media Containers [Brand names HXBL, WETEX, or Genesis Biomedical, with part numbers HX-K59, HX-K59-1, and “custom made” (saline); All lots] | FDA |
| 08 Aug 2022 | Counterfeit COVID-19 antigen rapid test kits found in Ontario | Health Canada |
| 02 Aug 2022 | North American Diagnostics Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits | FDA |
| 27 Jul 2022 | LumiraDx LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip, LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control [Catalog No. L017000109024, L017080109002; Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), 5000676 (Exp. 25-Aug-2022), 2002201428 (Exp. 01-Sept-2022)] | FDA |
| 20 Jul 2022 | Ortho-Clinical Diagnostics, Inc. Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960 [UDI-DI :10758750034413. All expired, in-date and future released lots] | FDA |
| 06 Jun 2022 | All Clean Natural Ltd. Surestrips Covid-19 Antigen Test [A03-50-422; 22010039, 22010040, 22010002, 21120019, 22010002, 22020004] | Health Canada |
| 06 Jun 2022 | All Clean Natural Ltd. Surestrips Rapid Response Covid-19 Antigen Rapid Test Device [Model or Catalogue Number: COV-19C25; Lot or Serial Number: 21100017] | Health Canada |
| 18 May 2022 | PROTERIXBIO ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit [No model number; Lots were not coded. All product will be recalled] | FDA |
| 18 May 2022 | USA Medical, LLC Diagnostic Kit SARS-cCo V Antigen Rapid Test [Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None] | FDA |
| 17 May 2022 | Woodside Acquisitions Inc Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | FDA |
| 11 May 2022 | SML Distribution, LLC Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold), may also be called Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, Lateral Flow COVID 19 Rapid Antigen Test, SKIPPACK COVID-19 Antigen Home Test [All lots: UL-AG-2110-05-Q, UL-AG-2111-02-Q, UL-AG-2112-01-Q, UL-AG-2112-02-Q, UL-AG-2201-03-Q] | FDA |
| 10 May 2022 | Mesa Biotech, Inc. Accula SARS-CoV-2 Test [Product Codes: QJR; REF: COV4100; Code Information UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016, P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017, P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019, P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011; Manufactured Dates: 30 Dec 2021 to 1 Jan 2022; 15 Jan 2022 to 23 Jan 2022] | FDA |
| 29 Apr 2022 | R-Biopharm Pty Ltd Control LQ COVID-19 IgG + IgM [K087M-6 Lot 06840] | TGA |
| 26 Apr 2022 | Thermo Fisher Scientific Amplitude Platform with TaqPath COVID-19 HT Kit [Catalog #A50883] | MHRA |
| 06 Apr 2022 | Seegen Allplex SARS-CoV-2 Variants II Assay [Product Code: RV10305X; All lots] | MHRA |
| 21 Mar 2022 | Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication | FDA |
| 02 Mar 2022 | ACON Laboratories, Inc. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) | FDA |
| 02 Mar 2022 | Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Test | FDA |
| 25 Feb 2022 | COVID-19 rapid antigen test kits and potential exposure to hazardous substances | Health Canada |
| 22 Feb 2022 | Hangzhou Testsea Biotechnology Co Ltd (sponsored by Australia Health Products Central Pty Ltd) Cellife Covid 19 Antigen Test Cassette pack of 5. An in vitro diagnostic medical device (IVD) [Batches: TL2A23, TL2A24, TL2A25, TL2A26 & TL2A27] | TGA |
| 07 Feb 2022 | E25Bio COVID-19 Direct Antigen Rapid Test | FDA |
| 07 Feb 2022 | SD Biosensor, Inc STANDARD Q COVID-19 Ag Home Test | FDA |
| 31 Jan 2022 | Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test [All lot codes] | FDA |
| 12 Jan 2022 | Luscient Diagnostics/ Vivera Pharmaceuticals/ EagleDx LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests | FDA |
| 10 Jan 2022 | Genrui SARS-COV-2 Rapid Antigen Self-Test | HPRA |
Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below.
| Posting Date | Title | |
|---|---|---|
* FDA = Food and Drug Administration, United States of America;
MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada;
TGA = Therapeutic Goods Administration, Australia;
HPRA = Health Products Regulatory Authority, Ireland;
HSA = Health Sciences Authority, Singapore