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Terminated

Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Remel, Lenexa, KS 66215

FDA Recall Z-1625-2008 · Posted 2008-05-14

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeLIB
Date Initiated2007-10-23
Date Terminated2008-07-16
Product Quantity554/2-ml packs

Reason for Recall

Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.

Firm Action

Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.

Root Cause

Other

Distribution Pattern

Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.

Official Source

View FDA Recall →

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

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