Recall Z-0546-2022— Microbiologics Inc
Class III · Terminated
Class III FDA medical device recall by Microbiologics Inc, initiated 2020-12-16, terminated 2023-01-12. It names one FDA 510(k) clearance: K861022. 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). Reason: 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..
- Recalling firm
- Microbiologics Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-12-16
- Terminated
- 2023-01-12
- Firm location
- Saint Cloud, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.