Princeton Biomeditech Recalls Status Flu A + B Test Kits
Princeton Biomeditech is recalling 90 kits of the Status Flu A + B Test due to reports of dual positive results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors (dual positive results) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling/testing errors.
Plain-English summary
Princeton Biomeditech Corporation is recalling 90 kits of the Status Flu A + B Test, manufactured in Monmouth Junction, NJ. The product is an in vitro rapid qualitative test intended for professional and laboratory use to detect influenza type A and type B nucleoprotein antigens from nasal swabs and aspirates.
The recall was initiated due to reports of dual positive results, where the test indicated positive results for both Flu A and Flu B simultaneously. The affected product is identified by Catalog Number 36022 and Lot number 441H11. The recall covers 90 kits, with 22 tests per kit.
The product was distributed nationwide, including the states of New Jersey, New York, and Pennsylvania. Users should stop using the affected test kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. 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, nasopharynge
- Manufacturer
- Princeton Biomeditech Corp
Distribution
Part of a larger recall action
This product is one of 3 recalled by Princeton Biomeditech Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Princeton Biomeditech Corp
See all →- HighPregnancy Test Kits Recalled for False Negative Results
FDA (Devices) · 2024-11-06
- ModeratePrinceton Biomeditech Recalls Poly stat Flu A & B Test Kits
FDA (Devices) · 2012-09-12
- ModeratePrinceton Biomeditech Recalls Orasure QuickFlu Rapid A+B Test Kits
FDA (Devices) · 2012-09-12
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02