FDA Device recall Z-0695-2016
D-10 Rack Loader
- FDA Device
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of D-10 Rack Loader by Bio Rad Laboratories, citing on a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0695-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-15 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
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 instrument control, data collection, and analysis.
Reason
On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
Identifiers
| code_info | All codes - 2006 to present |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0695-2016%22
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