Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laborator
FDA device recall Z-1537-2014 · posted 2014-05-02 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Reason for recall
- There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
- Action taken
- BIO-RAD Laboratories sent an URGENT: MEDICAL DEVICE LETTER in the US on April 8. 2014 and worldwide with letters sent to customers and subsidiaries on April 14, 2014. Subsidiaries were asked to translate the letter and distribute to all affected customers Custormer were asked to complete a CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the Bio-Rad CSD Regulatory Affairs Department at the number provided to confirm that you have received this important information
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JPD
- Quantity affected
- 457 kits
- Distribution
- Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.
- Date initiated
- 2014-04-08
- Date posted
- 2014-05-02
- Date terminated
- 2014-05-30
- 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 |
|---|---|---|
| VARIANT II B-THALASSEMIA (K991127) | Bio-Rad | 1999-06-10 |