Siemens N Antiserum to Human IgG Recall for High-Dose Performance Failure
Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.
What this means for you
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: Class II medical device recall for a diagnostic reagent with performance specification failure. The product presents a risk of harm through inaccurate test results in clinical diagnostics. No illnesses or injuries have been reported, but the deficiency in a clinical diagnostic test meets the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics is recalling N Antiserum to Human IgG (2mL variant) intended for use with BN II System and BN ProSpec System analyzers.
The reagent is not meeting expected High-Dose Hook Effect performance specifications. Specifically, it is failing to meet expected performance thresholds of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (cerebrospinal fluid). This performance deficiency may affect the accuracy of IgG measurements at high concentrations.
The affected lot is 153088, with distribution nationwide. Future lots may also be impacted and will include an instruction note in the reagent package if affected.
Laboratory facilities using this reagent should follow guidance from Siemens Healthcare Diagnostics regarding continued use and appropriate corrective actions.
The recalled product
- Product
- N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Affected units
- 373
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SIEMENS HEALTHCARE DIAGNOSTICS INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · SIEMENS HEALTHCARE DIAGNOSTICS INC
See all →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · diagnostic failure
See all →- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- HighLuminex VERIGENE Gram Negative Blood Culture Test Recalled
FDA (Devices) · 2025-06-11
- HighChevrolet Bolt battery diagnostic software may miss defective modules
NHTSA · 2024-06-27
- HighBD SARS-CoV-2 Reagent Kits Recalled for False Negative Test Results
FDA (Devices) · 2024-06-12
- ModerateBD Phoenix Yeast ID Panel Recalled for Incorrect Substrate Placement
FDA (Devices) · 2024-04-10