PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immuno…

Recall date

September 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1220-2018

FDA classification

Class III

Brand / firm

PerkinElmer Life and Analytical Sciences, Wallac, OY

Sold / distributed

Distributed to CT and TX.

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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