Recall Z-1299-2023 ยท JJH Clinical Sample Concentrator
Entopsis , Inc.
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
| Date | Mar 29, 2023 (initiated Feb 21, 2023) |
| Status | Open, Classified |
| Reason | Presence of misleading label statements on the product label. |
| Root cause | 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 revise |
| Quantity | 397 units |
| Distribution | Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.