remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS
FDA device recall Z-2928-2011 · posted 2011-08-03 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- Organism strains may fail to consistently produce confluent growth
- Action taken
- 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 distributors were further instructed to notify their customers if they further distributed the product. If you have inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 or 913-888-0939.
- Root cause
- Other
- Status
- Terminated
- Product code
- JSO
- Quantity affected
- 223/10-pack boxes
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-04-21
- Date posted
- 2011-08-03
- Date terminated
- 2013-06-21
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAEMOPHILUS TEST MEDIUM (AGAR) (K892928) | Remel Co. | 1989-06-13 |