Device 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
Z-1220-2018
Product summary
- Event
- Event 79198
- Status
- Terminated
- Classification
- Class III
- Quantity
- 240
- Official record key
device-enforcement:Z-1220-2018
Official wording
Reason: 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.
Code information: Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30
Distribution pattern: Distributed to CT and TX.
Derived failure modes
-
Unknown
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.