FDA Enforcement
Class II
Terminated
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.
Recall: Z-1956-2016
·
Reported June 22, 2016
Enforcement
- Recall Number
- Z-1956-2016
- Event ID
- 74212
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beckman Coulter Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 22, 2016
- Initiation Date
- May 17, 2016
- Classification Date
- June 13, 2016
- Termination Date
- August 26, 2016
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232, United States
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.
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 Info
Serial No. 505143, 504805, 501368, 504231
Distribution
US, Morocco, Venezuela
Quantity
4 units total (1 unit in US)