Z-0166-2016 Class II Terminated
FDA device recall Z-0166-2016 was initiated by Perkin Elmer Life Sciences Inc on August 24, 2015 and is designated Class II. Reason for recall: 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 corr… The recall status is terminated (terminated January 21, 2021). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2015
- Initiation Date
- August 24, 2015
- Termination Date
- January 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product 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 for Recall
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.
Distribution Pattern
US distribution to FL, GA, and NV; and Canada
Code Information
Software Version 1.6