Z-0376-2007

Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test...

Name: Z-0376-2007 Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test...
Creator: Bio-Rad Laboratories Inc
Published: 2006-11-17
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2006-11-17 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the... on 2006-11-17. The reason FDA records is "The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0376-2007
Status: Terminated
Initiated: 2006-11-17
Posted: 2007-01-25
Terminated: 2007-11-28
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.
Product code: JIT Calibrator, Secondary
Reason for recall: The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.
Quantity in commerce: 900 kits, 43 sets distributed.
Distribution: Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.
Product codes and lots: Diluent lot number AA61508, Catalog number for recalled diluent: 220-0119, expiration date 11/30/07 Catalog number for whole kit: 220-0201. Reorder pack lot numbers 2006 1537, 2006 1555, 2006 1561, 2006 1557, 2006 1597, 2006 1600, 2006 1745, 2006 2007. Expiration dates on hte above catalog numbers: 04/30/2007, except for 2006 1557, which is 2/28/07. The diluent is packaged with either HbA1c Calibrators (cat number 220-0128, lot number S61409, exp. date 5/31/2007), or HbA2/F/A1c calibrators (cat number 220-218, exp date 5/31/07. Calibrator diluent that comes with the kit has an expiration date of AA61408

Product code JIT

K041444Class IIBio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc. / cleared 2004-06-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)