Drug recall
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of…
FDA recall event 91723 · Class II · Entopsis, Inc.
Key facts
| Event ID | 91723 |
|---|---|
| Recall numbers | Z-1295-2023, Z-1296-2023, Z-1297-2023, Z-1298-2023, Z-1299-2023, Z-1300-2023, Z-1301-2023 |
| Recalling firm | Entopsis , Inc. |
| Product type | Devices |
| Products | PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples, PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples, PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of…, PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples, PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological… and 2 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of misleading label statements on the product label. |
| Initiation date | Feb 21, 2023 |
| Report date | Apr 5, 2023 |
| City | Medley |
| State | FL |
| Country | United States |
| FEI number | 3016994927 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: