Organon Teknika recalls Vitek 2 reagent cards with potential for false antibiotic resistance results, false negative ESBL tests, and false positive urea reactions. Affected lots listed in the recall notice.
This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards
Organon Teknika is recalling specific Vitek 2 reagent cards that could produce false test results. Using these cards might lead to incorrect antibiotic resistance readings, missed ESBL infections, or false positive urea tests.
The reagent cards may have compromised top seal integrity, causing false readings. This could lead to incorrect antibiotic resistance results, false negative ESBL tests, or false positive urea reactions in laboratory testing.
Laboratory users who have the listed Vitek 2 reagent cards with specific lot numbers. Those testing for antibiotic resistance or infections are most at risk of inaccurate results.
Check the product label for the reagent card type (GN ID, GP ID, ANC ID, AST-GNOR, etc.) and the lot number listed in the recall notice. The affected lots are detailed in the manufacturer's notice.
Look for the lot number on the reagent card label to see if it matches the affected lots listed in the recall notice.
The recall is due to potential compromised test card top seal integrity that could cause false antibiotic resistance results, false negative ESBL tests, or false positive urea reactions.
Specific reagent cards with lot numbers listed in the recall notice, including GN ID (lot 2410602403), GP ID (lot 2420806103), ANC ID (lot 2440811203), and others.
No action is required if your card lot number is not listed. Only affected lots need verification.
We’ve drafted a message you can send Organon Teknika to request your refund or repair — edit it as you like.
Subject: Recall Z-0962-2019 — Organon Teknika Organon Teknika Hello, I own a Organon Teknika that is covered by recall Z-0962-2019 from Organon Teknika. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
