Product Wiki · Recalls · U.S. FDA — Device Enforcement

DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human… — recall Z-1237-2019

U.S. FDA — Device Enforcement · Finland · 2019-01-10 · Class II

As described by U.S. FDA — Device Enforcement: 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.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1237-2019
Date of alert
2019-01-10
Country / jurisdiction
Finland
Risk level
Class II
Risk type
recall
Brand
PerkinElmer Life and Analytical Sciences, Wallac, OY
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Reported risk: hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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