Z-2251-2020Class II

Accelerator APS Aliquoter Module, List number: 07L40 -

Name: Z-2251-2020 Accelerator APS Aliquoter Module, List number: 07L40 -
Creator: Abbott Laboratories
Published: 2020-04-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-04-02 / Terminated / root cause: software

FDA source

Abbott Laboratories began a recall of Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and... on 2020-04-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2251-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-02
Posted: 2020-06-03
Terminated: 2021-04-28
Recalling firm: Abbott Medical
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.
Product code: CEM Electrode, Ion Specific, Potassium
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.
Root cause tag: software
FDA 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 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).
Quantity in commerce: 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.
Product codes and lots: All serial numbers in the field

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2251-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2251-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-03

Product code CEM

K093318Class IIAccelerator ApsAbbott Laboratories / cleared 2010-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)