The Recall Desk
ModerateFDA (Devices)·Z-1632-2023·Announced 2023-05-31

Siemens Atellica CH Toxicology Calibrator Reassignment Due to Positive Bias

Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II device recall with no reported illnesses or injuries. The hazard is a measurement bias in a calibration device, which is a technical issue rather than contamination or structural defect. Per the rubric, Class II recalls without reported incidents are classified as Moderate severity.

Plain-English summary

Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrator (TOX CAL) units and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias identified in these products. These in vitro diagnostic calibrators are used to calibrate toxicology assays on Siemens Atellica CH Analyzers for measuring acetaminophen, ethanol, and salicylate levels.

The affected calibrators were distributed across 6,546 units in the US and 3,681 units internationally to healthcare facilities in multiple countries including Canada, Mexico, Australia, and numerous European and Asian nations. Three lot numbers are affected: 74285306 (expiring May 31, 2023), 74536672 (expiring March 31, 2024), and 74732386 (expiring November 30, 2024).

Healthcare facilities using these calibrators should contact Siemens Healthcare Diagnostics for guidance on the reassignment and any necessary corrective action.

The recalled product

Product
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Clinical Chemistry / Laboratory Analyzer
Hazard
  • measurement-bias
  • calibration-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDi-DI: 00630414597614 Lot Numbers: 74285306 Exp. Date: 2023-05-31
  • 74536672 Exp Date: 2024-03-31
  • 74732386 Exp. Date: 2024-11-30

Distribution

Distributed nationwide across the United States.

Related recalls

Same category