AutoDELFIA Neonatal immunoreactive trypsin — Class III medical device recall Z-1220-2018
Terminated recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, reported 2018-09-12, distributed in CT, TX. The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to as
| Recall number | Z-1220-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A, Finland |
| Recall initiated | 2017-09-25 |
| Classified | 2018-08-31 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2018-09-06 |
| Distributed | CT, TX |
| Quantity | 240 |
| UPC / GTIN / UDI-DI | 06438147298716 |
| Lot numbers | 1065647901, 656479 |
| Expiration dates | 2019-04-30 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1220-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.