| Class 2 Device Recall Entopsis PCRopsis | |
Date Initiated by Firm | February 21, 2023 |
Date Posted | March 29, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1296-2023 |
Recall Event ID |
91723 |
Product Classification |
Clinical sample concentrator - Product Code JJH
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Product | PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples |
Code Information |
Lot number 4, Exp. 08/2023 |
Recalling Firm/ Manufacturer |
Entopsis , Inc. 7600 Nw 69th Ave Medley FL 33166-2521
|
For Additional Information Contact | Agustin Galecio 888-407-5070 |
Manufacturer Reason for Recall | Presence of misleading label statements on the product label. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 02/21/22023 by email. Those without a valid email address were mailed the notice via certified mail. The notice explained the issue and risk and requested the customer/user take the following actions:
"Entopsis Inc., requests that the product lots listed below - shipped/received before
February 8st, 2023 be promptly discontinued from use and discarded from inventory as per your non-hazardous waste disposal plan.The labeling of PCRopsis products was revised on
February 8th, 2022. Updated statements of intended use and revised instructions for use are available on www.pcropsis.com. If you are currently using or intend to use the PCRopsis
product lots affected by this recall please contact us at team@entopsis.net or 1-888-407-5070 (Monday to Friday 9.00 AM to 4.30 PM Eastern Time) to request a replacement. If you are a re-distributor of PCRopsis devices, notify your end customer with a copy of this letter. Please acknowledge the removal of affected product lots by filling out the attached acknowledgment form and returning it to us at team@entopsis.net.
Contact us at team@entopsis.net or 1-888-407-5070 - Monday to Friday 9.00 AM to 4.30 PM US Eastern Time (GMT -5) with any questions you may have."
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Quantity in Commerce | 6 units |
Distribution | Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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