D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Dr
FDA device recall Z-1299-2014 · posted 2014-03-27 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Reason for recall
- On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
- Action taken
- Bio-Rad Laboratories, Inc. sent an Urgent Medical Device correction letter dated February 27, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Customer medical Device Correction Response Form must be collected from each customer to ensure that they have received this communication. Forms should be faxed to the Bio-Rad CSD Regulatory Affairs Department at 510-741-3954 along with the completed Subsidiary Medical Device Correction Response Form. For questions regarding this recall call 570-741-6114.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 483 instruments in US. OUS to be determined.
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, China, India, SriLanka, Argentina, Paraguay, Uruguay, Chile, Peru ,Bolivia ,Mexico ,Panama, ,Costa Rica ,Ecuador, Venezu
- Date initiated
- 2014-02-27
- Date posted
- 2014-03-27
- Date terminated
- 2014-06-04
- Location
- Hercules, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| D-10 HEMOGLOBIN A1C (K031043) | Bio-Rad Laboratories, Inc. | 2003-08-27 |