FDAFDA · Food and drugs·Recall number Z-1220-2018
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
Published September 12, 2018 · Recall initiated: September 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Distributor
- Distributed to CT and TX.
- Lot
- Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Finland
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