FDAClass IIApril 5, 2023

PCRopsis Reagent Buccal recall

PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of…

Why was PCRopsis Reagent Buccal recalled?

Presence of misleading label statements on the product label.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Lot number 4, Exp. 08/2023

Product
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of…
Recalling firm
Entopsis , Inc.
Quantity
6 units
Distribution
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Recall date
April 5, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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