Recall Z-0546-2022 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
| Date | Dec 16, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | 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. |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS Micro-Bio-Logics, Apr 4, 1986 |