Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system d

FDA device recall Z-2251-2020 · posted 2020-06-03 · Terminated

Recall details

Recalling firm

Abbott Laboratories

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.

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).

Root cause

Software Design Change

Status

Terminated

Product code

CEM

Quantity affected

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.

Date initiated

2020-04-02

Date posted

2020-06-03

Date terminated

2021-04-28

Location

Irving, TX

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