Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Number (SMN): 10309217 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Number (SMN): 10309217
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31, 9520341 Exp. Date: 2024-03-31
Products Sold
UDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31; 9520341 Exp. Date: 2024-03-31
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2 due to Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
Recommended Action
Per FDA guidance
Siemens issued Urgent Medical Device Corrections (UMDC) ACHC23-03.A.US and ACHC23- 03.A.US.CHC to US customers via FedEx beginning on 04/05/2023. An Urgent Field Safety Notices (UFSN) ACHC23-03.A.OUS and ACHC23-03.A.OUS.CHC issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 04/05/2023. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Until the updated lot-specific value sheets are available on Document Library, keep a copy of this letter as a reference for the updated salicylate calibrator values. Perform the instructions provided in Additional Information section below. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026