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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
Related Medical Device Recalls
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Z-1295-2023 - PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples 2 03/29/2023 Entopsis , Inc.
Z-1296-2023 - PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples 2 03/29/2023 Entopsis , Inc.
Z-1297-2023 - PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples 2 03/29/2023 Entopsis , Inc.
Z-1301-2023 - 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 extraction from a variety o... 2 03/29/2023 Entopsis , Inc.
Z-1299-2023 - 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 transp... 2 03/29/2023 Entopsis , Inc.
Z-1300-2023 - 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 sa... 2 03/29/2023 Entopsis , Inc.
Z-1298-2023 - 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 that facilitate lysis of m... 2 03/29/2023 Entopsis , Inc.
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