DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product C...

FDA Device Recall #Z-1237-2019 — Class II — January 10, 2019

Recall Summary

Recall Number Z-1237-2019
Classification Class II — Moderate risk
Date Initiated January 10, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm PerkinElmer Life and Analytical Sciences, Wallac, OY
Location Turku, N/A
Product Type Devices
Quantity 31 kits (10 in US, 21 in ROW)

Product Description

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 Pattern

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

Lot / Code Information

Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI: (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604

Other Recalls from PerkinElmer Life and Analytical Scien...

Recall # Classification Product Date
Z-1239-2019 Class II AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for th... Jan 10, 2019
Z-1238-2019 Class II AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for th... Jan 10, 2019
Z-1541-2018 Class II Specimen Gate Screening Center, Part Number 500... Nov 17, 2017
Z-1692-2018 Class II NeoBase Succinylacetone Assay Solution, Product... Nov 2, 2017
Z-1220-2018 Class III AutoDELFIA Neonatal immunoreactive trypsin(ogen... Sep 25, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.