Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0546-2022 — KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)

U.S. FDA — Device Enforcement · United States · 2020-12-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0546-2022
Date of alert
2020-12-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Microbiologics Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
70845357028623
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.