D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibra

FDA device recall Z-2889-2011 · posted 2011-07-27 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories Inc

Reason for recall

Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.

Action taken

Bio-Rad Laboratories Inc sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected D-10 Dual customers and Bio-Rad subsidiaries on July 11, 2011 via FedEx or fax. The letters identified the product, the problem, and the action needed to be taken. The letters ask that inventory be examined and affected reorder pack lots be quarantined and destroyed according to local, state and federal regulations. All D-10 Dual customers were instructed to review their chromatograms generated from these lots. If the calibration has passed with good chromatography, the controls are within specification, and the F, A1c, and A2 peaks elute in their specified retention time windows for the patient samples, the customer may continue to use and report results with the affected buffer lots. The letters include a chart showing Good Patient Chromatogram with Correct Retention times and Failed Calibrator Chromatogram with late retention times. If calibration fails and/or late retention times cause one or more peaks to be misidentified, affected reorder packs should be destroyed. The correction letters and response form should be translated, if necessary, and distributed to all affected customers. Tracking documentation should be compiled for all customers who receive the Medical Device Correction letter. The Medical Device Correction Response Forms should be completed and returned by fax to Bio-Rad CSD Regulatory Affairs at 510-741-3954 or a PDF copy to Jackie_Buckley@bio-rad.com

Root cause

Other

Status

Terminated

Product code

LCP

Quantity affected

418

Distribution

Worldwide -- USA (nationwide) including the states of: AR, CA, CT, FL, HI, IN, MD, MN, MO, MS, NJ, NY, OH, PA, RI, TX. and the countries of: Brazil, Canada, China, England, France, India, Italy, Mexic

Date initiated

2011-07-11

Date posted

2011-07-27

Date terminated

2012-03-12

Location

Hercules, CA

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