Remel, Inc Recall 92444
Description: Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Remel, Inc Recall 92444 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2038-2023 |
| Event ID | 92444 |
| Event Description | Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use. |
| Product Type | Devices |
| Distribution | Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution. |
| Quantity | 1,296 packs |
| Recall Reason | The test medium may not perform as intended. |
| Device Classification | 20230705 |
| Device Code Info | REF R04033 lot numbers and expiration dates: Lot 619859 Exp. 2023-03-23, Lot 629086 Exp. 2023-03-31, Lot 629087 Exp. 2023-03-31, Lot 631001 Exp. 2023-04-11, Lot 634496 Exp. 2023-04-18, Lot 635369 Exp. 2023-04-19, Lot 645950 Exp. 2023-05-11, Lot 648004 Exp. 2023-05-18, and Lot 651372 Exp. 2023-05-23. UDI-DI #00848838004476. REF R01503 lot numbers and expiration dates: Lot 623548 Exp. 2023-03-28, Lot 631958 Exp. 2023-04-12, Lot 641527 Exp. 2023-05-02, Lot 644542 Exp. 2023-05-09, and Lot 648125 Exp. 2023-05-16. UDI-DI #00848838001932. |
| Center Classification Date | 20230629 |
| Recall Initiation Date | 20230531 |
| Recalling Firm | Remel, Inc |
| Initial Notification | Letter |
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