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RABS
RANDOX LABORATORIES LIMITED · Model RP3857 · UDI-DI 05055273205091
JJF
Prescription
10
510(k) clearances
93
Adverse events
13
Recalls
32
Facilities
Description
The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-15 | Vital Scientific N.V. | During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in |
| 2018-09-07 | Vital Scientific N.V. | The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the co |
| 2016-01-18 | Vital Scientific N.V. | Instrument stopped working due to a software lockup, and no patient results are produced. |
| 2012-02-01 | Roche Molecular Systems, Inc. | Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, |
| 2012-01-10 | Vital Scientific N.V. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| 2012-01-10 | Vital Scientific N.V. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| 2012-01-10 | Vital Scientific N.V. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| 2007-08-30 | Roche Diagnostics Corp. | False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries sh |
| 2007-05-21 | Roche Molecular Systems, Inc. | For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent sta |
| 2005-11-23 | Beckman Coulter Inc | Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0 |
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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.