Official recall record
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithiu
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-07-10
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00630414611037
- Brand on record
- Siemens Healthcare Diagnostics, Inc.
What the authority reported
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)
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-07-13 · US FDA — Medical Devices
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL - 2026-07-13 · US FDA — Medical Devices
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL - 2026-07-06 · US FDA — Medical Devices
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
All 38 official recall notices naming Siemens Healthcare Diagnostics, Inc. on this site →
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