Z-1220-2018 Class III Terminated
FDA device recall Z-1220-2018 was initiated by PerkinElmer Life and Analytical Sciences, Wallac, OY on September 25, 2017 and is designated Class III. 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… The recall status is terminated (terminated September 6, 2018). Affected quantity: 240.
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- September 25, 2017
- Termination Date
- September 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240
Product Description
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
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.
Distribution Pattern
Distributed to CT and TX.
Code Information
Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30