Recall Z-0314-2024 ยท OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
MEDLINE INDUSTRIES, LP - Northfield
BLOOD CULTURE KIT, REF DYNDH1647B
| Date | Nov 16, 2023 (initiated Nov 1, 2023) |
| Status | Open, Classified |
| Reason | This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 11/01/2023 via email. The notice explained the issue and requested that the destruction of the affected kits. Consignees were also instructed to notify all parties if the kits were transferred. |
| Quantity | 1890 kits |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.