FDA Medical Device Recalls (openFDA)
Abbott Laboratories: CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics Division, Santa Clara, CA 05054
- Recall number
- Z-2019-2011
- Recalling firm
- Abbott Laboratories
- Product
- CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics Division, Santa Clara, CA 05054
- Status
- Terminated
- Initiated
- 2011-03-15
- Posted
- 2011-04-29
- Terminated
- 2011-11-22
- Reason
- The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Root cause
- Pending
- Action
- Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.
- Quantity
- 174 total units, all varieties
- Distribution
- Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
- Lot, serial or model codes
- List Number 08H67-01; lot numbers: 35678BG, 35682BG to 35759BG, 35761BG to 35768BG, 35771BG, 34163BG, 34283BG, 34090BG, and 34862BG.
- 510(k) numbers
- ["K061667"]
- 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