VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM c
FDA device recall Z-1589-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- Some product ROM cards have an incorrect program loaded and are unable to be updated.
- Action taken
- The firm initiated its recall on March 18, 2008 by issuing a recall notice to customers and subsidiaries via e-mail. Not all VARIANT -Thalassemia Short ROM Cards are affected. Inventory should be examined and quarantine the product subject to this Recall. Contact your regional Bio-Rad office for ROM Card replacement or if you have questions.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JPD
- Quantity affected
- 64 kits total
- Distribution
- Product was distributed to 17 consignees and 7 subsidiaries Worldwide. Distribution included to states of CA, TX, WI, VA, UT, PA, TN, OH, FL, MA, OR, AR, IL, MD, CO, and NY, and countries of UK, Austr
- Date initiated
- 2008-03-18
- Date posted
- 2008-09-11
- Date terminated
- 2009-11-10
- 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 BETA-THALASSEMIA SHORT PROGRAM (K924122) | Bio-Rad | 1993-03-11 |