Z-1220-2018Class III

AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of...

Name: Z-1220-2018 AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of...
Creator: PerkinElmer Life and Analytical Sciences, Wallac, OY
Published: 2017-09-25
License: https://open.fda.gov/license/

Wallac Oy / initiated 2017-09-25 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer Life and Analytical Sciences, Wallac, OY began a recall of AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood... on 2017-09-25. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1220-2018
Classification: Class III
Status: Terminated
Initiated: 2017-09-25
Posted: 2018-10-11
Terminated: 2018-09-06
Recalling firm: Wallac Oy
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
Product code: JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Actions to be taken: Inspect your inventory of AutoDELFIA Neonatal IRT kits for batch number 1065647901 and replace the Quality Control Certificate included in the kit packaging with the revised certificate attached to this letter. If you have already used the kit lot there is no need to retest the samples reported if the results of the controls included in the assay were within your established acceptance range. Complete and return the enclosed response form identifying the quantity of affected kits in your possession. Please inform others affected in your organization accordingly. To comply with regulatory requirements we require that you complete the enclosed Response Form and return it.
Quantity in commerce: 240
Distribution: Distributed to CT and TX.
Product codes and lots: Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1220-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1220-2018	Class III	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31

Product code JNO

K110274Class IAutodelfia Neonatal Irt KitWallac Oy, A Subsidiary of Perkinelmer, Inc. / cleared 2011-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)