# FDA recall Z-1541-2018

> **PerkinElmer Life and Analytical Sciences, Wallac, OY** · Class II · device recall initiated 2017-11-17.

## Product

Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version)    Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

## Reason for recall

Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.

## Distribution

Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of :  Belgium, Canada, Denmark, Italy, and United Kingdom.

## Key facts

- **Recall number:** Z-1541-2018
- **Recalling firm:** PerkinElmer Life and Analytical Sciences, Wallac, OY
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-17
- **Report date:** 2018-05-09
- **Termination date:** 2021-08-12

- **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-1541-2018

## Citation

> AI Analytics. FDA recall Z-1541-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1541-2018. Source: US FDA. Licensed CC0.

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