Microbiologics Inc Recall 89380
Description: KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Microbiologics Inc Recall 89380 Information
Status | Terminated |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0544-2022 |
Event ID | 89380 |
Event Description | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls. |
Product Type | Devices |
Distribution | US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam. |
Quantity | 47 packs (94 units) |
Recall Reason | Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. |
Device Classification | 20220209 |
Device Code Info | Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381 |
Center Classification Date | 20220131 |
Recall Initiation Date | 20210224 |
Recalling Firm | Microbiologics Inc |
Initial Notification | Letter |
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