Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit Recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY Due to The Quality Control Certificate for certain AutoDELFIA Neonatal...
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
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
Quantity: 240
Why Was This Recalled?
The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
Where Was This Sold?
This product was distributed to 2 states: CT, TX
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