Z-1898-2011

Device brochure, labeled in part : BIO -RADL70242709 VARIANT TM II TURBOHemoglobin A 1C***Cartridge...

Name: Z-1898-2011 Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge...
Creator: Bio-Rad Laboratories Inc
Published: 2009-12-08
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2009-12-08 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories Inc began a recall of Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard... on 2009-12-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1898-2011
Status: Terminated
Initiated: 2009-12-08
Posted: 2011-04-06
Terminated: 2011-06-29
Recalling firm: Bio-Rad Laboratories Inc.
Product: Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercules, CA 94547***" Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Model Number(s): 270-2417 (Kit), with 270-2420 (Cartridge set) Code(s): LCP Listing Number(s): DO48707 for CDM 3.6T software Expiration date(s): Lot 70292242 EXP. Mar 31, 2010 and Lot 70292318 EXP. Jan. 31, 2010

Product code LCP

K063400Class IIVariant II Turbo Hemoglobin A1c Program, Hemoglobin Testing System with Cdm 4.0Bio-Rad Laboratories, Inc. / cleared 2006-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)