Medical device manufacturer, Macherey-Nagel GmbH & Co. KG, has issued a medical device safety alert concerning its Medi-Test Combi 11 [Reference: 93060; Lot: 650303] – urine test strips.
The manufacturer stated that in a small number of packages the test field for the parameter nitrite was not sealed onto the strip during the production of the test strips. There is thus the possibility that the parameter nitrite is interpreted visually or instrumentally as "false negative". As nitrite plays a role in the assessment of urinary tract infections, a false-negative result means that an infection is not recognised or recognised late, and appropriate therapeutic measures might be delayed. The manufacturer advises that affected users should check if the nitrite test paper is present before use of the test strips.
The following actions will be taken by the manufacturer and supplier: -
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 30 March 2021