Recall Z-0632-03 ยท JPK Mixture, Hematology Quality Control
Abbott Laboratories
Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT PART A Model/List Number 01H77-01 (4x3.8L), 01H75-01A (3.8L)
| Date | Mar 12, 2003 (initiated Jan 10, 2003) |
| Status | Terminated |
| Reason | Product may elicit fluorescent signal interference due to bacterial contamination. |
| Root cause | Other |
| Action | On 1/31/03, the firm initiated the recall and their notification was via letters requesting 'locate and discard' affected device. |
| Quantity | 8826 units |
| Distribution | Product was released for distribution to 428 consignees in U.S. and 17 foreign consignees. The U.S. States include: AL, AZ, CA, CO, FL, GA, IA, MN, MO, NY, NC, SC, TN, TX and UT; and foreign accounts include: Argentina, Canada and Puerto Rico. Product was distributed to 10 U.S. Government accounts: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.