Q-Prep
COULTER Q-PREP Immunology Workstation
5manufacturers in China registered for this device type
4catalogue numbers in this listing
8recalls on this code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Zhejiang Biorear Biotechnology Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JQW |
| Device type | Station, Pipetting And Diluting, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2750 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100V | In distribution | |
| 240V | In distribution | |
| 115V | In distribution | |
| 230V | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Caplugs/Evergreen | Caplugs, Inc. | 37 |
| Janus G3 | Caliper Life Sciences, Inc. | 31 |
| Alinity mp | Abbott Molecular, Inc. | 10 |
| Fontus | Caliper Life Sciences, Inc. | 8 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| Quaero | Zhejiang Biorear Biotechnology Co., Ltd. | 5 |
| Freedom EVO® | Tecan Schweiz AG | 5 |
| Janus G3 Blood iQ | Caliper Life Sciences, Inc. | 4 |
| Globe Scientific | Globe Scientific, LLC | 4 |
| Janus G3 Automated Workstation | Caliper Life Sciences, Inc. | 3 |
| PhD lx | Bio-Rad Laboratories Inc. | 3 |
| BD MicroProbe™ Processor | Becton, Dickinson AND Company | 3 |
Showing 12 of 150. All products under Station, Pipetting And Diluting, For Clinical Use
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-04-11 | Class II | Labeling False and Misleading | The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause | 468 units total (51 units in US) | 2013-02-11 |
| 2012-01-20 | Class II | Device Design | The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent. | 36 units total (15 units in the US) | 2012-10-02 |
| 2011-01-18 | Not classified | Other | The recall was initiated after erroneous, though potentially credible, results due to intermittent reagent level sense failures could be generated. During these failures, the instrument fails to produce a warning that a reagent vial is low | 369 units (140 in the U.S.) | 2014-09-02 |
| 2010-08-12 | Not classified | Mixed-up of materials/components | The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. Due to the size difference in | 391 units total (193 in US) | 2012-04-04 |
| 2010-01-21 | Not classified | Other | The recall was initiated after Beckman Coulter confirmed reports of potential dilution of reagent vials loaded onto the Preppies or PrepPlus 2 systems. Affected systems have a syringe pump with part number A46748 (see illustrations below) w | 193 units in total | 2012-04-04 |
| 2010-01-21 | Not classified | Other | The recall was initiated after Beckman Coulter confirmed reports of potential dilution of reagent vials loaded onto the Preppies or PrepPlus 2 systems. Affected systems have a syringe pump with part number A46748 (see illustrations below) w | 193 units in total | 2012-04-04 |
| 2007-08-30 | Not classified | Software design | Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the “Run Results” report. The software | 6 | 2009-01-13 |
| 2003-03-28 | Not classified | Other | Software problem may cause the instrument to skip the probe-wash step before processing different reagents. | 91 | 2003-10-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA.
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