FDAClass IIISeptember 12, 2018

AutoDELFIA Neonatal immunoreactive trypsin(ogen) recall

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

Why was AutoDELFIA Neonatal immunoreactive trypsin(ogen) 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in…
Recalling firm
PerkinElmer Life and Analytical Sciences, Wallac, OY
Quantity
240
Distribution
Distributed to CT and TX.
Recall date
September 12, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls