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
FDA Recall Z-1220-2018 · Posted None
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Recalling FirmPerkinElmer Life and Analytical Sciences, Wallac, OY
Recall StatusTerminated
Product CodeJNO
Date Initiated2017-09-25
Date Terminated2018-09-06
Product Quantity240
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Distributed to CT and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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