PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCR
Summary
The FDA issued a Class II for PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 7 by Entopsis , Inc.. Reason: Presence of misleading label statements on the product label..
Details
Source
Device Recall
External ID
Z-1301-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
Lot/Code Info: a) REF 787001, Lot Numbers: 4, Exp. 05/2023; b) REF 787002, Lot Numbers: 4, Exp. 05/2023; 5, Exp. 07/2023; c) REF 787003, Lot Numbers: 5 Exp. 07/2023
Quantity Affected: 94 units
Reason for Recall
Presence of misleading label statements on the product label.
Distribution
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-21
Company
Medley, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Entopsis , Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Entopsis , Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Entopsis , Inc. have FDA actions?
Entopsis , Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1301-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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