ClearanceBrief
Recall Z-0475-2019 ยท KHO Fluorometer, For Clinical Use

Tosoh Bioscience Inc

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 immunoreacti

DateSep 28, 2018
StatusTerminated
ReasonThere 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 calibra
Root causeComponent design/selection
ActionOn 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 additiona
Quantity7
DistributionUS Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.