Recall Z-1588-2008 ยท JPD Hemoglobin A2 Quantitation
Bio-Rad Laboratories Inc
VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104
| Date | Sep 11, 2008 (initiated Mar 18, 2008) |
| Status | Terminated |
| Reason | Some product ROM cards have an incorrect program loaded and are unable to be updated. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924122 | VARIANT BETA-THALASSEMIA SHORT PROGRAM Bio-Rad, Mar 11, 1993 |