KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling the KWIK-STI GBS QC Set (Live Culture) with catalog number 8164, lot number 8164-78, due to an incorrect expiration date on one component within the set. The affected component is the KWIK-STIK negative control (catalog number 0243U, lot number 243-48-5), which was labeled with an expiration date of 7/31/2020 when the correct expiration date should have been 7/31/2022. The product was distributed nationwide in Alabama, California, Colorado, Illinois, Maryland, Missouri, Mississippi, New Mexico, Ohio, Oregon, Pennsylvania, Texas, and Vermont.
The recall was issued because the mislabeled expiration date could cause users to discard a product that was still viable, or potentially use an expired product if the incorrect date went unnoticed. The source document does not specify what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for 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. Distribution: US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT. Quantity: N/A Lot/code info: Main Product Codes: Catalog Number: 8164, Lot Number: 8164-78, UDI: 70845357028623, Expiration date: 09/30/2021. Affected Component Codes: Catalog Number: 0243U, Lot Number: 243-48-5, UDI: 10845357004083, Expiration Date on Label: 07/31/2020, Correct Expiration Date: 07/31/2022.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.