Recall Z-0166-2016— Perkin Elmer Life Sciences Inc
Class II · Terminated
Class II FDA medical device recall by Perkin Elmer Life Sciences Inc, initiated 2015-08-24, terminated 2021-01-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Perkin Elmer Life Sciences Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-24
- Terminated
- 2021-01-21
- Firm location
- Turku, N/A, Finland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.