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Entopsis , Inc. FDA Recalls
7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL,Class IIFeb 21, 2023Presence of misleading label statements on the product label |
| PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samplesClass IIFeb 21, 2023Presence of misleading label statements on the product label |
| PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free Class IIFeb 21, 2023Presence of misleading label statements on the product label |
| PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REFClass IIFeb 21, 2023Presence of misleading label statements on the product label |
| PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samClass IIFeb 21, 2023Presence of misleading label statements on the product label |
| PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRClass IIFeb 21, 2023Presence of misleading label statements on the product label |
| PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extrClass IIFeb 21, 2023Presence of misleading label statements on the product label |