FDA recall Z-1220-2018

Product

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

Reason for recall

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.

Distribution

Distributed to CT and TX.

Key facts

Status

Terminated

Initiation date

2017-09-25

Report date

2018-09-12

Termination date

2018-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Turku, N/A, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1220-2018