VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components: Elution Buffer A

FDA device recall Z-3159-2011 · posted 2011-09-06 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories, Inc.

Reason for recall

The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle.

Action taken

The firm, BIO-RAD, sent a "Medical Device Correction" letter dated July 28, 2011 to all consignees/customers via Fed Ex on August 8, 2011. The letter described the product, problem and actions to be taken. The customers were informed that they could continue to use and report results with the affected buffer lot and the stability studies will continue until lot expiration date. The consignees were instructed to distribute this letter to all customers that have received the affected lot and to distribute the MEDICAL DEVICE CORRECTION RESPONSE FORM only to those customers that request replacement Elution Buffer B. In addition, the customers were to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, Attention: BIO-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad office or 510-724-7000.

Root cause

Employee error

Status

Terminated

Product code

LCP

Quantity affected

40

Distribution

Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.

Date initiated

2011-07-28

Date posted

2011-09-06

Date terminated

2011-11-01

Location

Hercules, CA

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