Reported May 9, 2018 · Terminated
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version)…
PerkinElmer Life and Analytical Sciences, Wallac, OY
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: PerkinElmer Life and Analytical Sciences, Wallac, OY · Mustionkatu 6 · Turku, N/A · N/A
Is this the product you have?
- Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
- Lot codes and dates
- All software versions from 1.0 to 1.8 (current software version)
- Amount recalled
- 8
Where it was sold
Why it was recalled
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
This product could cause temporary or reversible health problems — stop using it.
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