FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
- Recall number
- Z-0173-2020
- Recalling firm
- Abbott Laboratories
- Product
- Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
- Status
- Terminated
- Initiated
- 2019-05-09
- Posted
- not on file
- Terminated
- 2020-10-07
- Reason
- The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued letters on 5/9/2019 to the consignees who had the installed instruments with the affected serial numbers. The letters were issued via FedEx priority overnight express.
- Quantity
- 22 analyzers with tubing
- Distribution
- Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.
- Lot, serial or model codes
- Tubing lot #2018-10-16; Instrument serial numbers 007689, 007690, 007691, 007692, 007705, 007706, 007707, 007708, 007709, 007728, 007694, 007695, 007697, 007766, 007767, 007768, 007765, 007710, 007699, 007700, 007701, and 007703.
- 510(k) numbers
- ["K081495"]
- 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