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.
Enforcement
- Recall Number
- Z-0965-2014
- Event ID
- 66947
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bio-Rad Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 19, 2014
- Initiation Date
- November 22, 2013
- Classification Date
- February 10, 2014
- Termination Date
- March 20, 2014
- Address
- 4000 Alfred Nobel Dr, N/A, Hercules, CA, 94547-1803, United States
Description
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.
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.
Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014 64000331 5/31/2014 64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014 ( 64002240 08/3112014 64002241 11/30/2014
Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
2906 kits (318 Kits in US; 2588 kits internationally)