—#87309

Product

remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).

FDA product code: JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K850291
Affected lot / code info: Lot Number 833352, Exp. 2009.12.22.

Why it was recalled

The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm issued two different recall letters dated December 8, 2009 via regular mail. One letter was addressed to Microbiology Laboratory Supervisor and the other to Distributors. Both letters explained the reason for recall, requested the customer discard all remaining units in their possession, and complete the enclosed Product Inventory Checklist to indicate the amount of product that was discarded. The letter issued to distributors also requests they notify their customers to the laboratory level and the Product Inventory Checklist has a block to be marked indicating they have notified their customers. Direct questions to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2009-12-08
Posted by FDA: 2010-01-15
Terminated: 2011-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87309. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.