Device product
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.
Z-1956-2016
Product summary
- Event
- Event 74212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units total (1 unit in US)
- Official record key
device-enforcement:Z-1956-2016
Official wording
Reason: 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.
Code information: Serial No. 505143, 504805, 501368, 504231
Distribution pattern: US, Morocco, Venezuela
Derived failure modes
-
Unknown
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.