PerkinElmer Life and Analytical Sciences, Wallac, OY: Medical Device Recall in 2018 - (Recall #: Z-1220-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: September 25, 2017

Date Posted: September 12, 2018

Recall Number: Z-1220-2018

Event ID: 79198

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.

Status: Terminated

Product Quantity: 240

Code Information:

Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30

Distribution Pattern:

Distributed to CT and TX.

Voluntary or Mandated:

Voluntary: Firm initiated