Atellica CH HDLC 11537213Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · HDL Cholesterol (HDLC) Atellica CH Assay 1792 Tests · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 10, 2023Class IIOpen, Classified
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
Z-2474-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL devices
- AU OSR6196Beckman Coulter, Inc. · Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1 recall0 reports
- AU OSR6296Beckman Coulter, Inc. · Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1 recall0 reports
- HDL-Cholesterol Gen.4 07528582190Roche Diagnostics GmbH · LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL6 reports
- HDL-Cholesterol Gen.4 08057877190Roche Diagnostics GmbH · LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL5 reports
- HDL-Cholesterol Gen.4 07528566190Roche Diagnostics GmbH · LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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