Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 12, 2012
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, 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 infection
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Princeton Biomeditech Corp recalled Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Jun… - a moderate-severity action.
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Jun… was recalled by Princeton Biomeditech Corp in September 12, 2012. Reason: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.. Check the official notice for the remedy. Verify recall #Z-2308-2012 with the FDA Devices before acting.
The recall
Princeton Biomeditech Corp issued this moderate-severity FDA Devices recall-There have been reports of dual positive (Flu A + Flu B positive) results being encountered..
- Moderate
- severity level
- Class II
- classification
- September 12, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2308-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2308-2012) was formally reported on September 12, 2012, with the manufacturer initiating the action on March 9, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Princeton Biomeditech Corp is listed as the recalling firm, operating out of Monmouth Junction, NJ. Federal records list the affected scope as 90 kits (22 tests per kit).
The documented reason for this recall is: There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Distribution data in the federal record shows the product reached: Nationwide Distribution-including the states of NJ, NY, and PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
90 kits (22 tests per kit)
Related Recalls
6
3 from same agency
Product description
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, 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2308-2012 |
| Date reported | September 12, 2012 |
| Date initiated | March 9, 2012 |
| Recalling firm | Princeton Biomeditech Corp |
| Firm location | Monmouth Junction, NJ |
| Affected scope | 90 kits (22 tests per kit) |
| Distribution | Nationwide Distribution-including the states of NJ, NY, and PA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2308-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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, 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.. Recalled by Princeton Biomeditech Corp. Units affected: 90 kits (22 tests per kit).
Why was this product recalled? ▼
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2012. Severity: Moderate. Recall number: Z-2308-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution-including the states of NJ, NY, and PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2308-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 12, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.