Recall Z-1299-2023— Entopsis , Inc.
Class II · Ongoing
Class II FDA medical device recall by Entopsis , Inc., initiated 2023-02-21. FDA's recall record names no specific 510(k) clearance for this event. Product: PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples. Reason: Presence of misleading label statements on the product label..
- Recalling firm
- Entopsis , Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-21
- Firm location
- Medley, FL, United States
Product description
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
Reason for recall
Presence of misleading label statements on the product label.
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