Medical DeviceApr 5, 2023
Entopsis PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000 recall — FDA Z-1298-2023
Presence of misleading label statements on the product label.
Class IIFDA: OngoingEntopsis, Inc.
Recall history in this database
Classification mix: Class II: 6.
Medical DeviceApr 5, 2023
Entopsis PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001 recall — FDA Z-1299-2023
Presence of misleading label statements on the product label.
Class IIFDA: OngoingEntopsis, Inc.
Medical DeviceApr 5, 2023
Entopsis PCRopsis Support: a) 1 mL, REF 787001 recall — FDA Z-1301-2023
Presence of misleading label statements on the product label.
Class IIFDA: OngoingEntopsis, Inc.
Medical DeviceApr 5, 2023
Entopsis PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001 recall — FDA Z-1300-2023
Presence of misleading label statements on the product label.
Class IIFDA: OngoingEntopsis, Inc.
Medical DeviceApr 5, 2023
Entopsis PCRopsis Activator: a) 1.5mL, REF 228001 recall — FDA Z-1297-2023
Presence of misleading label statements on the product label.
Class IIFDA: OngoingEntopsis, Inc.
Medical DeviceApr 5, 2023
Entopsis PCRopsis Reagent Buccal, IVD, REF 282001 recall — FDA Z-1296-2023
Presence of misleading label statements on the product label.
Class IIFDA: OngoingEntopsis, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Entopsis, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.