CLASS III Device recall · Reported 19 Feb 2014 · FDA Enforcement Report
D-10 Dual Program, which contains Update Kit D-10 A1c recalled
Bio-Rad Laboratories is recalling D-10 Dual Program, which contains Update Kit D-10 A1c program diskette, distributed nationwide in the US. The recall was initiated on 22 Nov 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0965-2014
- FDA event ID
- 66947
- Recalling firm
- Bio-Rad Laboratories, Hercules, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Nov 2013
- FDA classified
- 10 Feb 2014
- Reported
- 19 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Nov 2013 | Recall initiated by company | |
| 10 Feb 2014 | Classified by FDA | +80 days |
| 19 Feb 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bio-Rad Laboratories
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Platelia Toxo IgM recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled | Bio-Rad Laboratories | Other | Nationwide |
| Device | CLASS II | BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack recalled | Bio-Rad Laboratories | Packaging Defects | Nationwide |
| Device | CLASS II | BioPlex 2200, Anti-CCP Reagent Pack recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Other | Nationwide |
| Device | CLASS II | BioPlex 2200, Anti-CCP Calibrator Set recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Other | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |