Recall Z-2251-2020 ยท CEM Electrode, Ion Specific, Potassium
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.
| Date | Jun 3, 2020 (initiated Apr 2, 2020) |
| 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. |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093318 | ACCELERATOR APS Abbott Laboratories, Feb 19, 2010 |