FDAClass IIOctober 7, 2020

Oratect III Oral Fluid Drug Screen Device recall

Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device…

Why was Oratect III Oral Fluid Drug Screen Device recalled?

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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?

ALL Lots Within Expiry

Product
Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device…
Recalling firm
Ameditech Inc
Quantity
1,325 units
Distribution
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Recall date
October 7, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls