Recalls / —
—#100816
Product
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 product code
- JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K092407
- Affected 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
Why it was recalled
The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- Nationwide Distribution--including Puerto Rico.
Timeline
- Recall initiated
- 2011-05-11
- Posted by FDA
- 2011-06-28
- Terminated
- 2013-06-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #100816. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.