—#70849

Product

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

FDA product code: LIB — Device, General Purpose, Microbiology, Diagnostic
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot 521354

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2007-10-23
Posted by FDA: 2008-05-14
Terminated: 2008-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.