Entopsis , Inc. 2023-04-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1298-2023
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50… Recall
Issued April 5, 2023 · Entopsis , Inc.
In April 2023, Entopsis , Inc. recalled the PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Presence of misleading label statements on the product label.
What you should do
- 1 Stop using PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Entopsis , Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Entopsis , Inc.
- Category
- Health
- Recall date
- April 5, 2023
- Units affected
- Not reported
- Sold at
- Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
- Recall number
- FDA-Z-1298-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Entopsis , Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.