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Atellica CH DLDL
Siemens Healthcare Diagnostics Inc. · Model 11097632 · UDI-DI 00630414596181
1
510(k) clearances
13
Adverse events
9
Recalls
36
Facilities
Description
LDL Cholesterol Direct (D LDL) Atellica CH - RGT 1600T
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-17 | Beckman Coulter Inc. | Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. |
| 2023-01-27 | Siemens Healthcare Diagnostics, Inc. | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2018-10-08 | Ortho-Clinical Diagnostics | VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results |
| 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 |
| 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. |
| 2008-05-29 | Polymer Technology Systems, Inc. | The expiration date was extended by 20 weeks without justification. |
| 2003-08-15 | Beckman Coulter Inc | LDL Cholesterol component in controls are unstable. |
| 2003-02-10 | Beckman Coulter Inc | Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date. |
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