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 Assembly, List Number: 8921187101, CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
FDA Recall Z-0489-2011 · Posted 2010-11-29
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Reason for Recall
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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