The Recall Desk
ModerateFDA (Devices)·Z-1299-2014·Announced 2014-04-02

Bio-Rad D-10 Hemoglobin Testing System Software Recall

Bio-Rad is recalling D-10 Hemoglobin Testing Systems because the software may occasionally generate duplicate results with incorrect sample identifiers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a software data integrity error (duplicate results with mismatched IDs) rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling the D-10 Hemoglobin Testing System, Model number 220-0220. The recall involves 483 instruments in the United States, with the number of units outside the US to be determined. The product is distributed worldwide, including in the US, Canada, and numerous international locations.

The recall is due to a rare software issue where the D-10 system might generate an extra result. This error duplicates the result from the previous sample but pairs it with the Sample ID and Injection number from the next sample. This could lead to data integrity issues in hemoglobin analysis.

Healthcare facilities and laboratories using the D-10 Hemoglobin Testing System should contact Bio-Rad Laboratories for instructions on how to address the software issue. The recall is classified as Class II by the FDA.

The recalled product

Product
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
483

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model number: 220-0220

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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