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Microbiologics Inc Recall 89384

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

Microbiologics Inc Recall 89384 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0546-2022
Event ID89384
Event DescriptionKWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.
Recall ReasonThe 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.
Device Classification20220209
Device Code InfoMain 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.
Center Classification Date20220131
Recall Initiation Date20201216
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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