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Terminated

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 Recall Z-1733-2009 · Posted 2009-08-14

Recalling FirmRemel, Inc
Recall StatusTerminated
Product CodeJSY
Date Initiated2009-05-06
Date Terminated2009-10-15
Product Quantity118 packages

Reason for Recall

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

Firm Action

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.

Root Cause

Error in labeling

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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