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U.S. Department of Health and Human Services

Class 2 Device Recall AIA2000 Analyzer

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  Class 2 Device Recall AIA2000 Analyzer see related information
Date Initiated by Firm September 28, 2018
Create Date November 16, 2018
Recall Status1 Terminated 3 on May 29, 2020
Recall Number Z-0475-2019
Recall Event ID 81194
Product Classification Fluorometer, for clinical use - Product Code KHO
Product AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
Code Information Serial Nos. 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Ms. Bernadette O'Connell
800-248-6764
Manufacturer Reason
for Recall		 There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.
FDA Determined
Cause 2		 Component design/selection
Action On September 28, 2018, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Tosoh has taken the required actions to inspect the liquid suction pump during preventative maintenance and correct the instruments where this issue has been observed. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. If additional information is needed, please contact Tosoh Technical Support. " Continue using your instrument. o If there is an unexplained rise in the calibration rate and the AIA-2000 Analyzer serial number is listed above, please contact Tosoh Technical Support. o If the assay calibration is as expected, then at the next scheduled Preventive Maintenance (PM) visit, a Tosoh field service engineer will inspect the liquid suction pump and replace it as needed. " File this notice with your laboratory records and forward this information to others in your laboratory. " Complete and return the attached Acknowledgement Form by any of the listed methods. If you have obtained unexpected test results, delays in test result reporting, or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette O'Connell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in Commerce 7
Distribution US Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.
Total Product Life Cycle TPLC 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.
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