FDAClass IIApril 5, 2023

PCRopsis Activator: a) recall

PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples

Why was PCRopsis Activator: a) 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?

a) REF 282001: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; b) REF 228002: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; 5, Exp. 04/2023

Product
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Recalling firm
Entopsis , Inc.
Quantity
52 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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