Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Perkin Elmer Specimen Gate Recalled by Perkin Elmer Life Sciences Inc Due to It would be possible for an abnormal analytical...
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 Perkin Elmer Life Sciences Inc directly.
Affected Products
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Quantity: 6 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 3 states: FL, GA, NV
About Perkin Elmer Life Sciences Inc
Perkin Elmer Life Sciences Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report