Recall Z-2929-2011 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Remel Inc
remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
| Date | Aug 3, 2011 (initiated Apr 21, 2011) |
| Status | Terminated |
| Reason | Organism strains may fail to consistently produce confluent growth |
| Root cause | Other |
| Action | The firm, Remel, Inc., sent two "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letters one dated April 20, 2011 to: Microbiology Lab Supervisors and the second dated April 25, 2011 to:Distributors via regular mail. The letters described the product, problem and actions to be taken. The customers were instructed to to review their inventory for the listed product lot(s); discard all remaining units of the product lots; and complete and return the Product Inventory Checklist by May 9, 2011 regardless if they have affected product in the enclosed self-addressed, stamped envelope. The distrib |
| Quantity | 538/10-pack boxes |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892928 | HAEMOPHILUS TEST MEDIUM (AGAR) Remel Co., Jun 13, 1989 |