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.
This recall has been terminated (originally issued June 28, 2011).
- Company
- Remel Inc
- Recall Initiated
- May 11, 2011
- Posted
- June 28, 2011
- Terminated
- June 18, 2013
- Recall Number
- Z-2677-2011
- Quantity
- 187/10-packs and 261/100-packs
- Firm Location
- Lenexa, KS
- Official Source
- View on FDA website ↗
Reason for Recall
The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)
Distribution
Nationwide Distribution--including Puerto Rico.
Lot / Code Info
Cat. # R01821 (10 pack) - Lot 028251, exp. 2011.06.13; Cat. #R01822 (100 pack) - Lot 028252, exp. 2011.06.13; 028883, exp. 2011.06.14; 028884, exp. 2011.06.14; and 031922, exp. 2011.06.21
Root Cause
Process control
Action Taken
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.