Home › MERIDIAN BIOSCIENCE, INC. › ImmunoCard STAT! FLU A&B

ImmunoCard STAT! FLU A&B

MERIDIAN BIOSCIENCE, INC. · Model 782030 · UDI-DI 00840733101656

PSZ Prescription

510(k) clearances

169

Adverse events (3 deaths)

Recalls

Facilities

Description

ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal 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. Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.

Recalls

Date	Firm	Reason
2022-01-05	Becton Dickinson & Co.	May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the i
2020-09-25	Quidel Corporation	Due to false positive results.
2019-04-03	Becton Dickinson & Co.	Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagn
2019-04-03	Becton Dickinson & Co.	Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagn
2017-12-15	Quidel Corporation	The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.