Home › Response Biomedical Corp › RAMP® 200 CM Control Module
RAMP® 200 CM Control Module
Response Biomedical Corp · Model C2100 · UDI-DI 10627966005237
KHO
Prescription
10
510(k) clearances
4,533
Adverse events
32
Recalls
51
Facilities
Description
RAMP® 200 Control Module manages the sample test results that it receives from the Test Module.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-22 | Tosoh Bioscience Inc | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results. |
| 2020-01-10 | Tosoh Bioscience Inc | A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the |
| 2019-02-20 | Ortho-Clinical Diagnostics | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems |
| 2019-02-20 | Ortho-Clinical Diagnostics | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems |
| 2018-10-05 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the ana |
| 2018-10-05 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between t |
| 2018-09-28 | Tosoh Bioscience Inc | There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during th |
| 2018-09-28 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If |
| 2018-09-28 | Tosoh Bioscience Inc | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released softw |
| 2018-09-28 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.