--- title: "Entopsis , Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Entopsis , Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/entopsis-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Entopsis , Inc. recall records **7** reported ongoing 7 records in this archive. Latest source date Feb 21, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 21, 2023 FDA device enforcement ### [PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples](https://isitonrecall.com/recall/fda-device-z-1295-2023-pcropsis-bcsnano-1ml-ref-2276001-nucleic-acid-extraction-from-a-variety-of-biological-samples/) Presence of misleading label statements on the product label. Class II Reported ongoing Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania [Official source for PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1295-2023%22) Feb 21, 2023 FDA device enforcement ### [PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples](https://isitonrecall.com/recall/fda-device-z-1296-2023-pcropsis-reagent-buccal-ivd-ref-282001-extraction-free-pcr-from-bucca-swabs-no-transport-medium-nucl/) Presence of misleading label statements on the product label. Class II Reported ongoing Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania [Official source for PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport med...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1296-2023%22) Feb 21, 2023 FDA device enforcement ### [PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples](https://isitonrecall.com/recall/fda-device-z-1297-2023-pcropsis-activator-a-1-5ml-ref-228001-b-0-5ml-ref-228002-nucleic-acid-extraction-from-a-variety-of-b/) Presence of misleading label statements on the product label. Class II Reported ongoing Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania [Official source for PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a var...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1297-2023%22) Feb 21, 2023 FDA device enforcement ### [PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads tha...](https://isitonrecall.com/recall/fda-device-z-1298-2023-pcropsis-lysis-beads-ivdd-a-25-tubes-ref-597000-b-25-tubes-ref-597825-c-50-tubes-ref-597850-d-25-gra/) Presence of misleading label statements on the product label. Class II Reported ongoing Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania [Official source for PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 5...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1298-2023%22) Feb 21, 2023 FDA device enforcement ### [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, &swa...](https://isitonrecall.com/recall/fda-device-z-1299-2023-pcropsis-reagent-rvd-with-rvd-enhancer-a-1-ml-validation-use-only-ref-78336001-b-25-ml-ref-78336025/) Presence of misleading label statements on the product label. Class II Reported ongoing Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania [Official source for PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1299-2023%22) Feb 21, 2023 FDA device enforcement ### [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 var...](https://isitonrecall.com/recall/fda-device-z-1300-2023-pcropsis-reagent-rvd-rt-ivd-a-1-ml-ref-78378001-b-25-ml-ref-78378025-c-100-ml-ref-78378100-extractio/) Presence of misleading label statements on the product label. Class II Reported ongoing Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania [Official source for PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1300-2023%22) Feb 21, 2023 FDA device enforcement ### [PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extract...](https://isitonrecall.com/recall/fda-device-z-1301-2023-pcropsis-support-a-1-ml-ref-787001-b-0-25-ml-ref-787002-c-25-ul-ref-787003-improves-the-functionalit/) Presence of misleading label statements on the product label. Class II Reported ongoing Distribution: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania [Official source for PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1301-2023%22) ## Reasons in these listed records - Presence of misleading label statements on the product label. These examples come from this result page and are not a ranking of every recall reason. ## Checking Entopsis , Inc. ### Is there a recall on entopsis , inc. right now? This archive contains 7 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Entopsis , Inc.](https://isitonrecall.com/check/?q=Entopsis%20%2C%20Inc.) 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