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Take-up Tubes, 14 inch, Qty 100
ELITECHGROUP INC. · Model SS-044 · UDI-DI 03661540302336
1
510(k) clearances
157
Adverse events
11
Recalls
77
Facilities
Description
The Take-up tubes are intended to be used with the 3120 SWEAT•CHEK Sweat Conductivity Analyzer for sweat analysis for the laboratory diagnosis of cystic fibrosis. The tubes allow for a sweat specimen as small as 6 to 10 microliters to be measured.
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 do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observ |
| 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) |
| 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.