N Antiserum to Human IgG recall
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Why was N Antiserum to Human IgG recalled?
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 0405686900179VF Lot Number: 153088 Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package
- Product
- N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
- Recalling firm
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Quantity
- 373 PCK
- Distribution
- Nationwide
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)