Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, ...

FDA Device Recall #Z-2307-2012 — Class II — March 9, 2012

Recall Summary

Recall Number Z-2307-2012
Classification Class II — Moderate risk
Date Initiated March 9, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Princeton Biomeditech Corp
Location Monmouth Junction, NJ
Product Type Devices
Quantity 103 kits (22 tests per kit)

Product Description

Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Reason for Recall

There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

Distribution Pattern

Nationwide Distribution-including the states of NJ, NY, and PA.

Lot / Code Information

510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11

Other Recalls from Princeton Biomeditech Corp

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Z-0259-2025 Class II Osom Ultra hCG Combo Test- IVD immunoassay for ... Aug 23, 2024
Z-2308-2012 Class II Status Flu A + B Test Manufactured by Prince... Mar 9, 2012
Z-2306-2012 Class II Orasure QuickFlu Rapid A+B Test Manufactured f... Mar 9, 2012

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.