Reported Feb 9, 2022 · Terminated

KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus…

Microbiologics Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440

Is this the product you have?

  • KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U
  • Specifically affected componentKWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Lot codes and dates
  • Main Product CodesCatalog
  • Number8164
  • Lot Number8164-78
  • UDI70845357028623
  • Expiration date09/30/2021
  • Affected Component CodesCatalog
  • Number0243U
  • Lot Number243-48-5
  • UDI10845357004083
  • Expiration Date on Label07/31/2020
  • Correct Expiration Date07/31/2022
Amount recalled
N/A

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 12, 2023 · Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.