remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).
FDA Recall Z-0644-2010 · Posted 2010-01-15
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Recalling FirmRemel, Inc
Recall StatusTerminated
Product CodeJTZ
Date Initiated2009-12-08
Date Terminated2011-07-12
Product Quantity267 units
Reason for Recall
The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.
Firm Action
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
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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