N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards
Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic 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 medical device with a performance deficiency affecting diagnostic accuracy. No illnesses or injuries are reported in the source text, but the product presents a risk of harm through inaccurate test results. High-Dose Hook Effect failure in immunoassay systems could lead to misdiagnosis in patients with elevated antibody levels.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling N Antiserum to Human IgG (5mL variant), a reagent used in clinical laboratory immunoassay testing with the BN II and BN ProSpec systems. The product is failing to meet established performance standards for the High-Dose Hook Effect, which ensures accurate test results when antibody concentrations are very high.
The affected reagent batches do not reliably perform at the specified thresholds: up to 648 mg/L for immunoglobulin G in urine (IgGU) and up to 2,290 mg/L for immunoglobulin G in cerebrospinal fluid (IgGC). This performance failure may produce inaccurate test results, particularly in patients with elevated antibody levels, potentially compromising diagnostic accuracy.
The recall affects approximately 10,201 packs distributed nationwide. Clinical laboratories and healthcare facilities using affected lot numbers (153083, 153085, 153087A, 153090, 153095B, 153099A, 153004B) should immediately discontinue use and contact Siemens for replacement product.
The recalled product
- Product
- N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Affected units
- 10,201
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)
- UDI-DI: 0405686900179VF Lot Number: 153083
- 153085
- 153087A
- 153090
- 153095B
- 153099A
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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