Home / Recalls / Focus Diagnostics Inc / Z-1958-2014

Z-1958-2014 Class II Terminated

Recalled by Focus Diagnostics Inc — Cypress, CA

Recall Details

Product Type
Devices
Report Date
July 9, 2014
Initiation Date
May 15, 2014
Termination Date
December 31, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
614 kits

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution

Code Information

Model Number: MOL2650. All Lot Numbers. The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015.

Other recalls by Focus Diagnostics Inc

  • Z-1686-2017 Class II — Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and (February 15, 2017)
  • Z-1685-2017 Class II — Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitati (February 15, 2017)
  • Z-1274-2016 Class I — Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, (February 10, 2016)
  • Z-1272-2016 Class I — Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL14 (February 10, 2016)
  • Z-1273-2016 Class II — Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, (February 10, 2016)
  • Z-0238-2016 Class II — Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M (October 2, 2015)
  • Z-1454-2015 Class II — STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to J (March 15, 2015)
  • Z-1144-2014 Class II — Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the diff (February 4, 2014)
  • Z-0846-2014 Class II — Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Sim (January 10, 2014)
  • Z-0182-2013 Class III — West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, (October 3, 2012)