Recall Z-0489-2011 ยท GKZ Counter, Differential Cell
Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, CELL-DYN 4000 Vent Needle, List Number: 02H61-01, CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, CELL-DYN 4000 Vent Head As
| Date | Nov 29, 2010 (initiated Jul 23, 2010) |
| Status | Terminated |
| Reason | The Vent Needle, which is built into the Vent Head Assembly on the CELL-DYN Sapphire Instrument and which is used directly on the CELL-DYN 4000 Instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample. |
| Root cause | Process control |
| Action | Abbott Laboratories issued a Product Recall letter dated July 23, 2010 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were instructed to discard all affected vent needles and replace them with the needle included with the recall letter. Customers may contact customer support at 1-877-422-2688 concerning this recall. |
| Distribution | Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.