KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Reported: February 9, 2022 Initiated: December 16, 2020 #Z-0546-2022
Product 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)
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.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- N/A
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM). Recalled by Microbiologics Inc. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 9, 2022. Severity: Low. Recall number: Z-0546-2022.
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