Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS. The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures demonstrating gram-positive cocci on Gram stain.
FDA Recall Z-2677-2011 · Posted 2011-06-28
Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJSO
Date Initiated2011-05-11
Date Terminated2013-06-18
Product Quantity187/10-packs and 261/100-packs
Reason for Recall
The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)
Firm Action
Remel, Inc. sent an "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letter, dated May 10, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
The letter instructs customers to review their inventory and discard all remaining product lots. Additionally, customers are to complete the Product Inventory Checklist and indicate whether or not they desire replacement of the product or credit. A self-addressed , stamped envelope was enclosed in the letter to use to return the checklist.
Questions can be answered by contacting the Technical Services Department at 800-255-6730 or 913-888-0939.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution--including Puerto Rico.
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.