FDADecember 16, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

microbiologics

UPCs

7084535702862310845357004083

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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