Access 2 Immunoassay System recalled over fire hazard

Recall date

May 17, 2016

Source

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

Official notice title

Beckman Coulter Inc. recalls Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitati…

Recall number

Z-1956-2016

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

US, Morocco, Venezuela

Why it was recalled

Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.

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

What was recalled

Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.