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.
- Company
- Abbott Laboratories
- Recall Initiated
- April 2, 2020
- Posted
- June 3, 2020
- Terminated
- April 28, 2021
- Recall Number
- Z-2251-2020
- Quantity
- 11
- Firm Location
- Irving, TX
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.
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 / Code Info
All serial numbers in the field
Root Cause
Software Design Change
Action Taken
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).