Reported Apr 5, 2023 · Ongoing

PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of…

Entopsis , Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Entopsis , Inc. · 7600 Nw 69th Ave · Medley, FL · 33166-2521

Is this the product you have?

  • PCRopsis Supporta) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
Lot codes and dates
  • a) REF 787001
  • Lot Numbers
    • 4
    • Exp. 05/2023
    • b) REF 787002
  • Lot Numbers
    • 4
    • Exp. 05/2023
    • 5
    • Exp. 07/2023
    • c) REF 787003
  • Lot Numbers5 Exp. 07/2023
Amount recalled
94 units

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

Presence of misleading label statements on the product label.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:34 PM UTC

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