Bio-Rad D-10 Hemoglobin Testing System Software Recall
Bio-Rad is recalling D-10 Dual Program software due to incorrect cartridge count updates when switching programs.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a software programming error rather than a direct physical hazard.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling the D-10 Dual Program, which includes the Update Kit D-10 A1c program diskette. The recall involves 2,906 kits distributed in the United States and internationally.
The recall is being conducted because the D-10 A1c Dual Program Floppy was programmed incorrectly. This error causes cartridge injection counts to not update correctly when users switch between the D-10 Dual Short Program and the Extended Program on the D-10 Hemoglobin Testing System.
The affected products were distributed nationwide in the United States and internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand, and India. Users should contact Bio-Rad Laboratories for further instructions regarding the replacement or correction of the software.
The recalled product
- Product
- 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…
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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