FDAClass IIDecember 21, 2016

LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR recall

LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika…

Why was LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR recalled?

The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is an inflection point in the fluorescence signal.

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?

38161611

Product
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika…
Recalling firm
Roche Molecular Systems, Inc.
Quantity
24 pieces
Distribution
Nationwide Distribution
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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