Recall Z-1297-2023— 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 Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; 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 Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Reason for recall
Presence of misleading label statements on the product label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.