Class 2 Device Recall remel Haemophilus Test Medium (Agar)

• Date Initiated by Firm: April 21, 2011
• Date Posted: August 03, 2011
• Recall Status: Terminated on June 21, 2013
• Recall Number: Z-2928-2011
• 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), 100mm plates, 10/pk, Ref. #R01503. 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 014360, Exp. 2011.04.18; Lot 020424, Exp. 2011.04.26; and Lot 025985, Exp. 2011.05.09.
• 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: 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: 223/10-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