—#99915

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.

FDA product code: JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K892928
Affected lot / code info: Lot 014360, Exp. 2011.04.18; Lot 020424, Exp. 2011.04.26; and Lot 025985, Exp. 2011.05.09.

Why it was recalled

Organism strains may fail to consistently produce confluent growth

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2011-04-21
Posted by FDA: 2011-08-03
Terminated: 2013-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.