CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report
PCRopsis Activator: a) recalled by Entopsis
Entopsis is recalling PCRopsis Activator: a), distributed nationwide in the US. The recall was initiated on 21 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1297-2023
- FDA event ID
- 91723
- Recalling firm
- Entopsis, Medley, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Feb 2023
- FDA classified
- 29 Mar 2023
- Reported
- 5 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Feb 2023 | Recall initiated by company | |
| 29 Mar 2023 | Classified by FDA | +36 days |
| 5 Apr 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of misleading label statements on the product label.
Product as listed by the FDA
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Where it was distributed
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Questions about this recall
Is PCRopsis Activator: a) recalled?
Yes. Entopsis recalled PCRopsis Activator: a) on 21 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1297-2023.
Why was it recalled?
Presence of misleading label statements on the product label.
Which lots 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
Where was it sold?
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Entopsis
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PCRopsis Reagent Buccal, IVD recalled by Entopsis | Entopsis | Other | Nationwide |
| Device | CLASS II | PCRopsis Reagent Rvd-rt, IVD: a) recalled by Entopsis | Entopsis | Temperature Abuse | Nationwide |
| Device | CLASS II | PCRopsis Support: a) recalled by Entopsis | Entopsis | Other | Nationwide |
| Device | CLASS II | PCRopsis BCSNano recalled by Entopsis | Entopsis | Other | Nationwide |
| Device | CLASS II | PCRopsis Reagent Rvd with Rvd Enhancer: a), Validation Use Only recalled | Entopsis | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |