VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- March 18, 2008
- Posted
- September 11, 2008
- Terminated
- November 10, 2009
- Recall Number
- Z-1589-2008
- Quantity
- 64 kits total
- Firm Location
- Hercules, CA
Reason for Recall
Some product ROM cards have an incorrect program loaded and are unable to be updated.
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.
Lot / Code Info
Lot number 70080140 and 70080276
Root 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.