# FDA recall Z-1237-2019

> **PerkinElmer Life and Analytical Sciences, Wallac, OY** · Class II · device recall initiated 2019-01-10.

## Product

DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)  Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

## Reason for recall

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

## Distribution

Worldwide distribution - US Nationwide distribution. and countries of  Austria, Bolivia, UK,  Switzerland,Thailand, Finland.

## Key facts

- **Recall number:** Z-1237-2019
- **Recalling firm:** PerkinElmer Life and Analytical Sciences, Wallac, OY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-10
- **Report date:** 2019-05-08

- **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-1237-2019

## Citation

> AI Analytics. FDA recall Z-1237-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1237-2019. Source: US FDA. Licensed CC0.

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