Recall Z-2677-2011 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Remel Inc
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 setting
| Date | Jun 28, 2011 (initiated May 11, 2011) |
| Status | Terminated |
| Reason | The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA) |
| Root cause | Process control |
| 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 |
| Quantity | 187/10-packs and 261/100-packs |
| Distribution | Nationwide Distribution--including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092407 | REMEL SPECTRA MRSA Remel, Inc., Oct 8, 2010 |