Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Specimen Gate Screening Center Recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY Due to Potential errors in patient results generated by the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PerkinElmer Life and Analytical Sciences, Wallac, OY directly.
Affected Products
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.
Quantity: 8
Why Was This Recalled?
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Where Was This Sold?
Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
About PerkinElmer Life and Analytical Sciences, Wallac, OY
PerkinElmer Life and Analytical Sciences, Wallac, OY has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report