Simplexa Group A Strep Direct recall
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
Why was Simplexa Group A Strep Direct recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
- Recalling firm
- Focus Diagnostics Inc
- Quantity
- 41 units
- Distribution
- 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.
- Recall date
- April 13, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)