FDA Device recall Z-1220-2018
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(oge…
- FDA Device
- Class III
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class III recall of AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(oge… by Perkinelmer Life And Analytical Sciences Wallac Oy, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1220-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-25 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Life And Analytical Sciences Wallac Oy |
| Distribution | CT, TX |
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
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.
Identifiers
| code_info | Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1220-2018%22
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