Reported Feb 19, 2014 · Terminated
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules,…
Bio-Rad Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Rad Laboratories, Inc. · 4000 Alfred Nobel Dr · Hercules, CA · 94547-1803
Is this the product you have?
- D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
- Lot codes and dates
- Catalog number220-0201: Reorder Pack Lot No./Expiration
- date( 64002240 08/3112014 64002241 11/30/2014
200303223/31/2014200303373/31/2014640000815/31/2014640003315/31/2014640003325/31/20146400088808/31/20146400134404/30/20146400223911/30/2014
- Amount recalled
- 2906 kits (318 Kits in US; 2588 kits internationally)
Where it was sold
- Nationwide
Why it was recalled
D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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