FDA Enforcement
Class II
Terminated
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Recall: Z-0166-2016
·
Reported November 4, 2015
Enforcement
- Recall Number
- Z-0166-2016
- Event ID
- 72013
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Perkin Elmer Life Sciences Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 4, 2015
- Initiation Date
- August 24, 2015
- Classification Date
- October 26, 2015
- Termination Date
- January 21, 2021
- Address
- Laitun 4 Mustionkatu 6, N/A, Turku, N/A, N/A, Finland
Description
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Reason
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
Code Info
Software Version 1.6
Distribution
US distribution to FL, GA, and NV; and Canada
Quantity
6 units