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U.S. Department of Health and Human Services

Class 2 Device Recall remel Haemophilus Test Medium (Agar)

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  Class 2 Device Recall remel Haemophilus Test Medium (Agar) see related information
Date Initiated by Firm April 21, 2011
Date Posted August 03, 2011
Recall Status1 Terminated 3 on June 21, 2013
Recall Number Z-2929-2011
Recall Event ID 58684
510(K)Number K892928  
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS.

For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Code Information Lot 017075, Exp. 2011.04.18; lot 018116, Exp. 2011.04.21; Lot 020358, Exp. 2011.04.27; lot 023750, Exp. 2011.05.04; and lot 023851, Exp. 2011.05.05.
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Earleen C. Parks
913-895-4185
Manufacturer Reason
for Recall		 Organism strains may fail to consistently produce confluent growth
FDA Determined
Cause 2		 Other
Action The firm, Remel, Inc., sent two "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letters one dated April 20, 2011 to: Microbiology Lab Supervisors and the second dated April 25, 2011 to:Distributors via regular mail. The letters described the product, problem and actions to be taken. The customers were instructed to to review their inventory for the listed product lot(s); discard all remaining units of the product lots; and complete and return the Product Inventory Checklist by May 9, 2011 regardless if they have affected product in the enclosed self-addressed, stamped envelope. The distributors were further instructed to notify their customers if they further distributed the product. If you have inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 or 913-888-0939.
Quantity in Commerce 538/10-pack boxes
Distribution Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JSO and Original Applicant = REMEL CO.
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