Entopsis , Inc.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1295-2023Class IIPCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samplesFebruary 21, 2023
Z-1300-2023Class IIPCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 783781February 21, 2023
Z-1296-2023Class IIPCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport mediumFebruary 21, 2023
Z-1299-2023Class IIPCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF February 21, 2023
Z-1297-2023Class IIPCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a varieFebruary 21, 2023
Z-1301-2023Class IIPCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the February 21, 2023
Z-1298-2023Class IIPCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 5978February 21, 2023