Siemens Healthcare Diagnostics, Inc. Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry 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
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Siemens Material Number (SMN): 11097620, UDI DI: 00630414595627, Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), 232025 (11/01/2024).
Products Sold
Siemens Material Number (SMN): 11097620; UDI DI: 00630414595627; Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), 232025 (11/01/2024).
Siemens Healthcare Diagnostics, Inc. is recalling Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry due to Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Recommended Action
Per FDA guidance
An Urgent Medical Device Correction notification letter dated 12/19/23 was sent to customers. Actions to be Taken by the Customer: Siemens Healthineers recommends batch testing samples for Atellica CH IgM_2 as follows: 1. Remove and discard any Atellica CH IgM_2 reagent packs onboard the analyzer. 2. Load a single fresh Atellica CH IgM_2 reagent pack onto the analyzer. 3. Perform a Lot calibration and process Quality Control (QC). 4. Immediately process a batch of patient samples and conclude with a repeat run of QC. Patient results should not be reported until the QC performed at the end of the batch run has been assessed. - If the QC results are within the established range, patient results can be reported. - If the QC results are not within the established range, do not report patient results and repeat steps 1 4 above. 5. Remove and discard the Atellica CH IgM_2 reagent pack at the end of the batch run. Siemens Healthineers does not recommend using the ADVIA IgM_2 reagent on the Atellica CH or Atellica CI Analyzers. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 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. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your 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