remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenex
FDA device recall Z-0644-2010 · posted 2010-01-15 · Terminated
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.
- Action taken
- The recalling firm issued two different recall letters dated December 8, 2009 via regular mail. One letter was addressed to Microbiology Laboratory Supervisor and the other to Distributors. Both letters explained the reason for recall, requested the customer discard all remaining units in their possession, and complete the enclosed Product Inventory Checklist to indicate the amount of product that was discarded. The letter issued to distributors also requests they notify their customers to the laboratory level and the Product Inventory Checklist has a block to be marked indicating they have notified their customers. Direct questions to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JTZ
- Quantity affected
- 267 units
- Distribution
- Nationwide.
- Date initiated
- 2009-12-08
- Date posted
- 2010-01-15
- Date terminated
- 2011-07-12
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS (K850291) | Remel Co. | 1985-05-10 |