Bio-Rad D-10 Rack Loader Recalled for Potential Sample ID Error
Bio-Rad is recalling D-10 Rack Loaders because a rare configuration issue could assign patient results to incorrect sample IDs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential patient data errors.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling the D-10 Rack Loader (Model Number 220-0600). This hematology system is used for sample dilution, processing, and analysis of hemoglobin. The recall involves 165 units in the United States and 200 units internationally.
The recall is due to a rare potential to assign a patient result to an incorrect sample ID when the device is running in D10 Rack Loader configuration. This error could lead to incorrect patient data. The affected units were distributed worldwide, including in the United States, Canada, Australia, and various European and Asian countries.
Healthcare facilities and users should contact Bio-Rad Laboratories for instructions on how to address this issue. The recall covers all units manufactured from 2006 to present.
The recalled product
- Product
- D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrum
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Hazard
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)
- All codes - 2006 to present
Distribution
Distributed nationwide across the United States.
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