—#82111

Product

Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.

FDA product code: JSY — Kit, Identification, Mycobacteria
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot 763654, Exp. 2009.07.07

Why it was recalled

The plate labeling is incorrect, but the outer box labeling is correct

Root cause (FDA determination)

Error in labeling

Action the firm took

The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.

Timeline

Recall initiated: 2009-05-06
Posted by FDA: 2009-08-14
Terminated: 2009-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.