Reported Nov 4, 2015 · Terminated
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by…
Perkin Elmer Life Sciences Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Perkin Elmer Life Sciences Inc · Laitun 4 Mustionkatu 6 · Turku, N/A · N/A
Is this the product you have?
- Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
- Lot codes and dates
- Software Version 1.6
- Amount recalled
- 6 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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