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U.S. Department of Health and Human Services

Class 2 Device Recall Accelerator APS Aliquoter Module

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 Class 2 Device Recall Accelerator APS Aliquoter Modulesee related information
Date Initiated by FirmApril 02, 2020
Date PostedJune 03, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-2251-2020
Recall Event ID 85449
510(K)NumberK093318 
Product Classification Electrode, ion specific, potassium - Product Code CEM
ProductAccelerator 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.
Code Information All serial numbers in the field
FEI Number 3016438761
Recalling Firm/
Manufacturer		 Abbott Laboratories
1915 Hurd Dr
Irving TX 75038
Manufacturer 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.
FDA Determined
Cause 2		Software Design Change
ActionOn 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 Commerce11
DistributionWorldwide distribution - U.S. Nationwide distribution including in the states of NC, ND, SC, TN. The countries of United Kingdom, France, New Zealand, Pakistan, Turkey.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CEM
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