In-Vitro Diagnostic Medical Devices for COVID-19 NOT Listed Under MDACS (from 1 January 2022)

In-Vitro Diagnostic Medical Devices for COVID-19 NOT Listed Under MDACS (from 1 January 2022)


Summary of Safety Alerts

Starting from 1 January 2022, the summary includes some safety alerts related to medical devices not listed under MDACS reported by the trade or overseas authorities. 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.

Caption: Data Table
Posting Date Description of Product Source of Information *
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


Special Alerts

Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.

No record found



* 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