FDA Medical Device Recalls (openFDA)
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 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
- Recall number
- Z-0489-2011
- Recalling firm
- Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
- Product
- 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
- Status
- Terminated
- Initiated
- 2010-07-23
- Posted
- 2010-11-29
- Terminated
- 2011-09-01
- 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.
- Quantity
- not on file
- Distribution
- Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
- Lot, serial or model codes
- Manufacturing date codes between 01.Jan.2010 and 23.Jun.2010
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2919069
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28