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I.S.E. CL
RANDOX LABORATORIES LIMITED · Model D400-0013 · UDI-DI 05055273214871
CGZ
Prescription
10
510(k) clearances
158
Adverse events
11
Recalls
77
Facilities
Description
Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-10 | Ortho-Clinical Diagnostics | Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. |
| 2019-09-10 | Ortho-Clinical Diagnostics | Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. |
| 2018-08-28 | Abbott Laboratories, Inc | There is a potential to generate falsely elevated serum or plasma chloride results when using the product. |
| 2018-07-11 | Ortho-Clinical Diagnostics | The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) |
| 2018-07-11 | Ortho-Clinical Diagnostics | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observ |
| 2011-03-15 | OPTI Medical Systems, Inc | The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma |
| 2009-04-20 | OPTI Medical Systems, Inc | Outer box labeling shows an incorrect storage temperature range. |
| 2008-05-23 | Abbott Laboratories, Inc | Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample. |
| 2007-09-26 | Abbott Laboratories, Inc | Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the in |
| 2005-02-01 | Radiometer America Inc | The CI membrane units generate too low values for status and sensitivity during calibration. |
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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.