# FDA recall Z-1220-2018

> **PerkinElmer Life and Analytical Sciences, Wallac, OY** · Class III · device recall initiated 2017-09-25.

## 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.

## Distribution

Distributed to CT and TX.

## Key facts

- **Recall number:** Z-1220-2018
- **Recalling firm:** PerkinElmer Life and Analytical Sciences, Wallac, OY
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-25
- **Report date:** 2018-09-12
- **Termination date:** 2018-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Turku, N/A, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1220-2018

## Citation

> AI Analytics. FDA recall Z-1220-2018. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1220-2018. Source: US FDA. Licensed CC0.

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