Medical device manufacturer, BioMerieux, has issued a medical device safety alert concerning its VITEK 2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards. The affected devices, distributed in Hong Kong, are identified as the following:-
A potential issue was identified related to the top seal of card pouches containing the VITEK 2 test cards for the specified product lots.
The manufacturer's investigation concluded that the pouch top seal of the card lots manufactured on a specific card poucher (Poucher 1) between 10 and 29 August 2018 is potentially compromised. A small section of the top seal may be improperly sealed for the card lots.
According to the manufacturer, its studies have demonstrated that a Top Seal Integrity issue can allow entry of moisture, which can impact the test card reagents. Moisture sensitivity can lead to antibiotic degradation (loss of potency). The anticipated consequence would be elevated minimum inhibitory concentration (MIC) results, or false resistant results, of some antimicrobials. The antimicrobial class most affected by moisture is the beta-lactam class. This includes penicillins, cephalosporins, and carbapenems. The most moisture-sensitive of the beta-lactams is imipenems and therefore the best indicator of a Top Seal Integrity issue. Erythromycin and nitrofurantoin are also moisture sensitive, and therefore may also be indicators of a pouch breach.
For Vitek Identification cards, urea may be sensitive to moisture and a false positive reaction may occur. However, there is low risk of impact to identification result as the ID algorithm generally allows two atypical reactions and will still provide a correct identification with a high degree of confidence. The knowledge bases are designed to account for both typical and atypical strains so an aberrant reactions should have low impact on identification results.
Customers are asked to inspect stock levels for affected products. For the impacted lots, visually inspect the test card pouch to confirm it's impacted and if so, perform the "tug test" as described in the customer letter. If the defect is observed, destroy the associated test card(s). If the defect is not observed, continue testing as per normal procedure. It is not necessary to discard all cards from an impacted lot.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 22 January 2019