Recall Z-0546-2022
Microbiologics Inc · initiated December 16, 2020
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Codes / lots: 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.
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.
FDA-determined cause: Employee error
Action taken
Microbiologics notified customers on about 12/16/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to update records with the correct expiration date of 07/31/2022 and keep the letter for their records. Questions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.
Details
- Recall number
- Z-0546-2022
- Initiated
- December 16, 2020
- Terminated
- January 12, 2023
- Product code
- JTR – Kit, Quality Control For Culture Media
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN