DELFIA¿ hCG Kit — Class II medical device recall Z-1237-2019
Ongoing recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, reported 2019-05-08, distributed nationwide. hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
| Recall number | Z-1237-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A, Finland |
| Recall initiated | 2019-01-10 |
| Classified | 2019-04-26 |
| Reported by FDA | 2019-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BO, CH, FI, GB, TH |
| Quantity | 31 kits |
| UPC / GTIN / UDI-DI | 06438147009176 |
| Lot numbers | 1066489101, 1066647101, 1066660401, 664891, 666471, 666604 |
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.
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-1237-2019. 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.