Microbiologics recalls KWIK-STI GBS QC Set (Live Culture) with incorrect expiration date label on negative control component. Affected units have expiration date labeled as 7/31/2020 instead of 7/31/2022. No action required per recall details.
The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
Microbiologics is recalling a specific component of their KWIK-STI GBS QC Set (Live Culture) because the expiration date on the negative control 0243U is incorrectly labeled as 7/31/2020 instead of 7/31/2022. This could lead to using expired materials in testing, but the recall does not require immediate action.
The negative control component (0243U) has an expiration date incorrectly labeled as 7/31/2020 instead of 7/31/2022. Using expired materials could lead to inaccurate test results, but this does not pose a direct safety risk to users.
Users of the KWIK-STI GBS QC Set (Live Culture) with the specific negative control component (catalog number 0243U) are affected. Laboratory or medical professionals using this component for testing are most at risk.
Check for the KWIK-STI GBS QC Set (Live Culture) with catalog number 0243U, lot number 243-48-5, and expiration date labeled as 7/31/2020 on the negative control component.
Verify the expiration date on the negative control 0243U component; it should be 7/31/2022, not 7/31/2020.
The expiration date on the negative control 0243U component is incorrectly labeled as 7/31/2020 instead of 7/31/2022, which could lead to using expired materials in testing.
No action is required; the recall does not mandate stopping use or discarding the product.
Check for the KWIK-STI GBS QC Set with catalog number 0243U, lot number 243-48-5, and expiration date labeled as 7/31/2020 on the negative control component.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-0546-2022 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-0546-2022 from Microbiologics. 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.