Recall Z-2038-2023 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Remel, Inc
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.
| Date | Jun 29, 2023 (initiated May 31, 2023) |
| Status | Open, Classified |
| Reason | The test medium may not perform as intended. |
| Root cause | Under Investigation by firm |
| Action | The firm issued recall letters dated 5/31/2023 via mail on 5/31/2023 that were flagged as URGENT: Deliver to Micro Lab. The letter provides the reason for the field action, risk to health, the product and distribution information, and actions to be taken by the customer. The actions included the consignee review reported results by an appropriate technical expert. The letter should be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred. An Acknowledgement Form was enclosed for return to the firm |
| Quantity | 1,296 packs |
| Distribution | Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892928 | HAEMOPHILUS TEST MEDIUM (AGAR) Remel Co., Jun 13, 1989 |