Recall Z-2251-2020— Abbott Laboratories
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, initiated 2020-04-02, terminated 2021-04-28. It names one FDA 510(k) clearance: K093318. 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.. 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..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-02
- Terminated
- 2021-04-28
- Firm location
- Irving, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.