PCRopsis Reagent (Entopsis) - Label Misleading (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Entopsis Inc.
Lot Codes / Batch Numbers
a) REF 78378001, Lot Numbers: 4, Exp. 02/2023, 7, Exp. 07/2023, b) REF 78378025, Lot Numbers: 6, Exp. 06/2023, c) REF 78378100, Lot Numbers: 7, Exp. 07/2023
Products Sold
a) REF 78378001, Lot Numbers: 4, Exp. 02/2023; 7, Exp. 07/2023; b) REF 78378025, Lot Numbers: 6, Exp. 06/2023; c) REF 78378100, Lot Numbers: 7, Exp. 07/2023
Entopsis Inc. is recalling PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 783781 due to Presence of misleading label statements on the product label.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of misleading label statements on the product label.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026