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.
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: 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.
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