PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
Reported: April 5, 2023 Initiated: February 21, 2023 #Z-1300-2023
Product Description
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
Reason for Recall
Presence of misleading label statements on the product label.
Details
- Recalling Firm
- Entopsis , Inc.
- Units Affected
- 97 units
- Distribution
- Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
- Location
- Medley, FL
Frequently Asked Questions
What product was recalled? ▼
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples. Recalled by Entopsis , Inc.. Units affected: 97 units.
Why was this product recalled? ▼
Presence of misleading label statements on the product label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1300-2023.
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