Tosoh Bioscience Inc recalls AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich im…

Recall date

September 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0602-2019

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.

Why it was recalled

The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.