Beckman Coulter Inc.: Medical Device Recall in 2016 - (Recall #: Z-1956-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 17, 2016

Date Posted: June 22, 2016

Recall Number: Z-1956-2016

Event ID: 74212

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4 units total (1 unit in US)

Code Information:

Serial No. 505143, 504805, 501368, 504231

Distribution Pattern:

US, Morocco, Venezuela

Voluntary or Mandated:

Voluntary: Firm initiated