Microbiologics KWIK-STI GBS QC Set Recall: Incorrect Expiration Date Label
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63650-microbiologics-kwik-sti-gbs-qc-set-recall-incorrect-expiration-date.
Source Summary by GovInfoNow · govinfonow.com/recall/63650-microbiologics-kwik-sti-gbs-qc-set-recall-incorrect-expiration-date · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0546-2022
Cite this page
“Microbiologics KWIK-STI GBS QC Set Recall: Incorrect Expiration Date Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63650-microbiologics-kwik-sti-gbs-qc-set-recall-incorrect-expiration-date. Based on FDA recall #Z-0546-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0546-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Microbiologics- Category
Medical device
What to do — step by step
Check Expiration Date
Verify the expiration date on the negative control 0243U component; it should be 7/31/2022, not 7/31/2020.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
FDA distribution: “US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Illinois, Maryland, Mississippi, Missouri, New Mexico, Ohio, Oregon, Pennsylvania, Texas, Vermont.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this product?
No action is required; the recall does not mandate stopping use or discarding the product.
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Where this comes from
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.
- Official source: FDA Recall #Z-0546-2022 (December 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0546-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.