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U.S. Department of Health and Human Services

Class 2 Device Recall Remel Spectra MRSA

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 Class 2 Device Recall Remel Spectra MRSAsee related information
Date Initiated by FirmMay 11, 2011
Date PostedJune 28, 2011
Recall Status1 Terminated 3 on June 18, 2013
Recall NumberZ-2677-2011
Recall Event ID 59005
510(K)NumberK092407 
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
ProductRemel 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.
Code Information 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
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactEarleen C. Parks
913-895-4185
Manufacturer Reason
for Recall		The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)
FDA Determined
Cause 2		Process control
ActionRemel, 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.
Quantity in Commerce187/10-packs and 261/100-packs
DistributionNationwide Distribution--including Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JSO
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