Clinical Sample Concentrator
FDA adverse event reports and recall history for clinical sample concentrator (product code JJH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 286
- Deaths
- 1
- Injuries
- 28
- Malfunctions
- 251
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-07-12Open, ClassifiedSoftware design
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
- 2024-04-10Open, ClassifiedUnder Investigation by firm
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
- 2023-03-29Open, ClassifiedUnder Investigation by firm
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Presence of misleading label statements on the product label.
- 2023-03-29Open, ClassifiedUnder Investigation by firm
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
Presence of misleading label statements on the product label.
- 2023-03-29Open, ClassifiedUnder Investigation by firm
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Presence of misleading label statements on the product label.
- 2023-03-29Open, ClassifiedUnder Investigation by firm
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 microorganisms; nucleic acid extraction from a variety of biological samples
Presence of misleading label statements on the product label.
- 2023-03-29Open, ClassifiedUnder Investigation by firm
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
Presence of misleading label statements on the product label.
- 2023-03-29Open, ClassifiedUnder Investigation by firm
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
Presence of misleading label statements on the product label.
- 2023-03-29Open, ClassifiedUnder Investigation by firm
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 of biological samples
Presence of misleading label statements on the product label.
- 2022-12-07Open, ClassifiedNo Marketing Application
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.
Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to downstream applications.
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