Recall Z-0269-06 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054
| Date | Dec 6, 2005 (initiated Sep 20, 2005) |
| Status | Terminated |
| Reason | The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results. |
| Root cause | Other |
| Action | On September 20, 2005, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the recall. In February, the firm expanded its recall to all lots as a result of having identified an additional failure in a different lot. |
| Distribution | Distribution of DILUENT is worldwide to a total of 1,584 consignees. All CELL-DYN 1800 customers were notified via the Device Recall Letter. At the time of receipt of the letter, the customer may or may not have the recalled lots in their inventory. Therefore, the letter directed the customer to |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.