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
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0546-2022 |
| Event ID | 89384 |
| Event 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) |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT. |
| Recall 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. |
| Device Classification | 20220209 |
| Device Code Info | 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. |
| Center Classification Date | 20220131 |
| Recall Initiation Date | 20201216 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
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