PerkinElmer recalls Screening Center software versions 1.0-1.8 for potential false negative and positive patient results in newborn screening tests.
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
PerkinElmer is recalling its Specimen Gate Screening Center software versions 1.0 through 1.8 because they can produce false negative and false positive results in newborn screening tests. This could lead to incorrect health assessments for infants.
The software may generate false negative results (missing a condition) or false positive results (showing a condition that isn't present) in newborn screening tests. This could lead to incorrect health decisions for infants.
Healthcare professionals using the Screening Center for newborn screening programs. Infants receiving newborn screening tests are at risk of incorrect health assessments.
Check if you have the Specimen Gate Screening Center with part number 5002-0500 and software versions 1.0 through 1.8. The product is used in newborn screening programs by qualified laboratory personnel.
Identify the software version on your Screening Center device to see if it's between 1.0 and 1.8.
The recall is for the software used in newborn screening programs. If your lab uses the affected software, there could be false results.
The recall record does not specify a remedy or fix for this issue.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send PerkinElmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1541-2018 — PerkinElmer PerkinElmer Hello, I own a PerkinElmer that is covered by recall Z-1541-2018 from PerkinElmer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
