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HDL-Cholesterol Gen.4
Roche Diagnostics GmbH · Model 08057877190 · UDI-DI 07613336121306
LBS
Prescription
1
510(k) clearances
33
Adverse events
9
Recalls
45
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-08 | Beckman Coulter Ireland, Inc. | Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically sig |
| 2017-04-03 | Beckman Coulter Inc. | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results |
| 2016-08-02 | Alere San Diego, Inc. | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirm |
| 2015-05-07 | Roche Diagnostics Operations, Inc. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine |
| 2015-05-07 | Roche Diagnostics Operations, Inc. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2012-02-02 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type. |
| 2008-06-11 | Roche Diagnostics Corp. | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
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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.