PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extr

FDA device recall Z-1296-2023 · posted 2023-03-29 · Open, Classified

Recall details

Recalling firm

Entopsis , Inc.

Reason for recall

Presence of misleading label statements on the product label.

Action taken

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."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJH

Quantity affected

6 units

Distribution

Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania

Date initiated

2023-02-21

Date posted

2023-03-29

Location

Medley, FL