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Dimension Vista® Flex® reagent cartridge LITH
Siemens Healthcare Diagnostics Inc. · Model 10635870 · UDI-DI 00842768035326
1
510(k) clearances
12
Adverse events
7
Recalls
10
Facilities
Description
Lithium Flex® reagent cartridge, 180 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-19 | Siemens Healthcare Diagnostics, Inc. | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, whic |
| 2022-09-19 | Siemens Healthcare Diagnostics, Inc. | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, whic |
| 2022-02-09 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2020-06-05 | Siemens Healthcare Diagnostics, Inc. | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH. |
| 2019-06-28 | Sentinel CH SpA | Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARC |
| 2019-06-28 | Sentinel CH SpA | Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARC |
| 2006-05-15 | Beckman Coulter Inc | Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. |
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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.