Home / Recalls / Focus Diagnostics Inc / Z-1274-2016

Z-1274-2016 Class I Terminated

Recalled by Focus Diagnostics Inc — Cypress, CA

Recall Details

Product Type
Devices
Report Date
April 13, 2016
Initiation Date
February 10, 2016
Termination Date
June 16, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41 units

Product Description

Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455

Reason for Recall

Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.

Code Information

Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262. Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620. 3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.

Other recalls by Focus Diagnostics Inc

  • Z-1685-2017 Class II — Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitati (February 15, 2017)
  • Z-1686-2017 Class II — Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and (February 15, 2017)
  • 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-1958-2014 Class II — Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Si (May 15, 2014)
  • 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)