Reported Apr 13, 2016 · Terminated
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150,…
Focus Diagnostics Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Focus Diagnostics Inc · 11331 Valley View St · Cypress, CA · 90630-5366
Is this the product you have?
- Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452
- MOL1455) Model Number
MOL2150MOL1451MOL1452MOL1455
- Lot codes and dates
- Item Number MOL1451
- Lot/Serial
151870152535152359152550152551152756152770160008160009160198160201160248160262. Item Number MOL1455
- Lot/Serial
292302923229233294532945429669296702967129689296902969129692298452984629847298482984929850302713027230273302743027530609306103061130612306133061530616306173061930620. 3M Manufacturing Lot# (Pouch
- and White Box of 24 DAD)
21408872140332212742321595312154010216524021733192169601217609021815182181519219892421634862171337217609121652362183651218512922169812213066221037122082042205280225545622554562225778223095822334492265481 2258543
- Amount recalled
- 1845 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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