Company: Focus Diagnostics Inc
Date of Enforcement Report:6/25/2014
Class lI:
PRODUCT
Simplexa” Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa” Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Recall Number Z-1958-2014
REASON
Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa” Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.
RECALLING FIRM/MANUFACTURER
Focus Diagnostics Inc.,Cypress, CA on 5/5/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
614 kits
DISTRIBUTION
Nationwide
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