Recall Z-0376-2007
Bio-Rad Laboratories Inc · initiated November 17, 2006
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.
Codes / 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
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0376-2007
- Initiated
- November 17, 2006
- Posted by FDA
- January 25, 2007
- Terminated
- November 28, 2007
- Product code
- JIT – Calibrator, Secondary
- Quantity
- 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.
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA