Class II — Abbott Laboratories
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| 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. |
| Initiated | 2020-04-02 |
| Classified | 2020-06-03 |
| Terminated | 2021-04-28 |
| Recall number | Z-2251-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories (Z-2251-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85449/
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