—#180938

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.

FDA product code: CEM — Electrode, Ion Specific, Potassium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K093318
Affected lot / code info: All serial numbers in the field

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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).

Recalling firm

Firm: Abbott Laboratories
Address: 1915 Hurd Dr, Irving, Texas 75038

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-04-02
Posted by FDA: 2020-06-03
Terminated: 2021-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180938. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.