FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
- Recall number
- Z-2251-2020
- Recalling firm
- Abbott Laboratories
- Product
- Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
- Status
- Terminated
- Initiated
- 2020-04-02
- Posted
- 2020-06-03
- Terminated
- 2021-04-28
- Reason
- In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results.
- Root cause
- Software Design Change
- Action
- On 04/02/2020, Product Correction notices were mailed to customers via overnight service. Customers were asked to do the following to avoid the risk of contamination, take the following precaution: - Discard the Primary Tube flagged with Clot Detection error or manage it according to your laboratory guidelines considering that it may be diluted. - Call Customer Support in case the frequency of the Clot Detection Error increases (more than 5 consecutive Clot Detection Errors). - Please complete the included Abbott Customer Reply Form. - If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. - Retain this letter for your laboratory records. This information will be added to the Operations Manual, which is expected in Q2 2020. If you or any of the health care providers you serve have any questions regarding this information, please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).
- Quantity
- 11
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of NC, ND, SC, TN. The countries of United Kingdom, France, New Zealand, Pakistan, Turkey.
- Lot, serial or model codes
- All serial numbers in the field
- 510(k) numbers
- ["K093318"]
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 3016438761
- Firm city
- Irving
- Firm state
- TX
- 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