Recall Z-1589-2008
Bio-Rad Laboratories Inc · initiated March 18, 2008
Product
VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104
Codes / lots: Lot number 70080140 and 70080276
Reason for recall
Some product ROM cards have an incorrect program loaded and are unable to be updated.
FDA-determined cause: Mixed-up of materials/components
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.
Details
- Recall number
- Z-1589-2008
- Initiated
- March 18, 2008
- Posted by FDA
- September 11, 2008
- Terminated
- November 10, 2009
- Product code
- JPD – Hemoglobin A2 Quantitation
- Quantity
- 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, Australia, Canada, France, Singapore, New Zealand, Italy.
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1588-2008 | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250…Some product ROM cards have an incorrect program loaded and are unable to be updated. | 03/18/2008Terminated |