Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DELFIA¿ hCG Kit Recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY Due to hCG analyte concentrations may be decreased up to...

Date: January 10, 2019
Company: PerkinElmer Life and Analytical Sciences, Wallac, OY
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PerkinElmer Life and Analytical Sciences, Wallac, OY directly.

Affected Products

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.

Quantity: 31 kits (10 in US, 21 in ROW)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PerkinElmer Life and Analytical Sciences, Wallac, OY

PerkinElmer Life and Analytical Sciences, Wallac, OY has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report