Entopsis Recalls
7 recalls on record · April 5, 2023 to April 5, 2023 · Medical Devices
April 5, 2023Medical DevicesFDA
Entopsis , Inc. recalls PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCR
Hazard: Presence of misleading label statements on the product label.
April 5, 2023Medical DevicesFDA
Entopsis , Inc. recalls PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free
Hazard: Presence of misleading label statements on the product label.
April 5, 2023Medical DevicesFDA
Entopsis , Inc. recalls PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL,
Hazard: Presence of misleading label statements on the product label.
April 5, 2023Medical DevicesFDA
Entopsis , Inc. recalls PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF
Hazard: Presence of misleading label statements on the product label.
April 5, 2023Medical DevicesFDA
Entopsis , Inc. recalls PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological sam
Hazard: Presence of misleading label statements on the product label.
April 5, 2023Medical DevicesFDA
Entopsis , Inc. recalls PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extr
Hazard: Presence of misleading label statements on the product label.
April 5, 2023Medical DevicesFDA
Entopsis , Inc. recalls PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Hazard: Presence of misleading label statements on the product label.