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U.S. Department of Health and Human Services

Class 2 Device Recall Entopsis PCRopsis

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 Class 2 Device Recall Entopsis PCRopsissee related information
Date Initiated by FirmFebruary 21, 2023
Date PostedMarch 29, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1297-2023
Recall Event ID 91723
Product Classification Clinical sample concentrator - Product Code JJH
ProductPCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Code Information a) REF 282001: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; b) REF 228002: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; 5, Exp. 04/2023
Recalling Firm/
Manufacturer		 Entopsis , Inc.
7600 Nw 69th Ave
Medley FL 33166-2521
For Additional Information ContactAgustin 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
ActionThe 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."
Quantity in Commerce52 units
DistributionNationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Total Product Life CycleTPLC Device Report
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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