Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 m...

FDA Device Recall #Z-1401-2013 — Class II — April 16, 2013

Recall Summary

Recall Number Z-1401-2013
Classification Class II — Moderate risk
Date Initiated April 16, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alere San Diego, Inc.
Location San Diego, CA
Product Type Devices
Quantity 3975 kits

Product Description

Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.

Reason for Recall

The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for

Distribution Pattern

United States Nationwide Distribution

Lot / Code Information

Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13

Other Recalls from Alere San Diego, Inc.

Recall # Classification Product Date
Z-1702-2024 Class II Abbott Cholestech LDX Battery Kit, Model: 3LP65... Mar 1, 2024
Z-1508-2022 Class II The Cholestech LDX¿ System combines enzymatic m... Jun 24, 2022
Z-2475-2019 Class II Alere Cholestech LDX Analyzer, model # 14-874 c... Feb 15, 2019
Z-0418-2018 Class II Triage Drugs of Abuse Plus TCA 25 Test Kit, Mod... Nov 14, 2017
Z-0588-2017 Class II Alere Triage Total 5 Control Level 1, Model No.... Oct 12, 2016

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.