Siemens Atellica CH Immunoglobulin M Reagent Quality Control Bias
Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential negative bias in diagnostic test results, which qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 7,075 units (927 US, 6,148 international) of its Total Immunoglobulin M (IgM) in vitro diagnostic kit. The reagent is used with the Atellica CH analyzer to measure immunoglobulin M levels in patient samples via nephelometry/turbidimetry.
The recall addresses a potential for negative bias in quality control and patient sample results when using the Atellica CH Immunoglobulin M_2 reagent. This bias could affect the accuracy of test results.
Affected lot numbers are 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), and 232025 (11/01/2024). U.S. distribution was nationwide across most states and Puerto Rico; international distribution covered multiple countries including Argentina, Australia, Austria, Canada, Germany, France, Japan, Mexico, and United Kingdom.
Healthcare providers and laboratories using affected lots should discontinue use and contact Siemens Healthcare Diagnostics for product replacement instructions and guidance on quality control verification.
The recalled product
- Product
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (6)
- 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).
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · quality control bias
See all →- HighFREELITE Kappa Free Kit quality control bias recall
FDA (Devices) · 2021-07-14
- ModerateBinding Site recalls Optilite Freelite Mx Kappa Free Kits for quality control bias
FDA (Devices) · 2021-02-10
Similar recalls
- ModerateSiemens Atellica IM aTG Test Kits Recalled for Positive Bias
FDA (Devices) · 2019-05-08
- HighDiagnostic reagent kit recall: potential test result inaccuracy
FDA (Devices) · 2023-09-06
- HighSiemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias
FDA (Devices) · 2022-01-05
- HighLaboratory diagnostic test may produce inaccurate results from reagent carryover
FDA (Devices) · 2023-09-06
- ModerateSiemens Atellica CH Total Bilirubin Assay Recalled for Positive Bias
FDA (Devices) · 2020-04-01
- HighSiemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues
FDA (Devices) · 2022-04-20