CLASS II Device recall · Reported 12 Sep 2012 · FDA Enforcement Report
Poly stat Flu A & B Test recalled by Princeton Biomeditech
Princeton Biomeditech is recalling Poly stat Flu A & B Test, distributed nationwide in the US. The recall was initiated on 9 Mar 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2307-2012
- FDA event ID
- 62537
- Recalling firm
- Princeton Biomeditech, Monmouth Junction, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2012
- FDA classified
- 31 Aug 2012
- Reported
- 12 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 9 Mar 2012 | Recall initiated by company | |
| 31 Aug 2012 | Classified by FDA | +175 days |
| 12 Sep 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution-including the states of NJ, NY, and PA.
Questions about this recall
Is Poly stat Flu A & B Test recalled?
Yes. Princeton Biomeditech recalled Poly stat Flu A & B Test on 9 Mar 2012. The recall is Class II and its status is Terminated. Recall number Z-2307-2012.
Why was it recalled?
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Which lots are affected?
510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11
Where was it sold?
Nationwide Distribution-including the states of NJ, NY, and PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Princeton Biomeditech
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| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |