Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge

FDA device recall Z-1898-2011 · posted 2011-04-06 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories Inc

Reason for recall

Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.

Action taken

The firm, Bio-Rad, sent a "MEDICAL DEVICE CORRECTION" letter dated November 29, 2009 to all customers by Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 80080, please destroy the insert and use the new insert enclosed with the letter. 2) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 90170, they may continue using the insert. 3) Complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to: Bio-Rad CSD Regulatory Affairs Department at (510) 741-3954. If you have any questions, please call 510-724-7000 or contact your regional Bio-Rad office.

Root cause

Other

Status

Terminated

Product code

LCP

Quantity affected

51 kits (Lot # 70292242; 45 kits( Lot # 70292318)

Distribution

Worldwide distribution: USA including states of: CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA and WV; and countries including: France, Hong Kong, Italy, Korea and New Zealand.

Date initiated

2009-12-08

Date posted

2011-04-06

Date terminated

2011-06-29

Location

Hercules, CA

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