Home › Siemens Healthcare Diagnostics Inc. › RAPIDLab® 1200 Series 1245
RAPIDLab® 1200 Series 1245
Siemens Healthcare Diagnostics Inc. · Model 10321844 · UDI-DI 00630414515557
1
510(k) clearances
171
Adverse events
19
Recalls
46
Facilities
Description
RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1245 can determine pH, pCO2, pO2, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-29 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 |
| 2025-07-29 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 |
| 2020-01-15 | Abbott Point Of Care Inc. | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different |
| 2018-12-17 | Roche Diagnostics Corporation | New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D mod |
| 2016-10-11 | Abbott Laboratories | Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21). |
| 2016-08-11 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere wit |
| 2016-07-05 | Siemens Healthcare Diagnostics Inc | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States |
| 2016-04-13 | Beckman Coulter Inc. | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6 |
| 2016-01-11 | Horiba Instruments Inc | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantip |
| 2015-08-24 | Siemens Healthcare Diagnostics Inc | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
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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.