N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 104
Summary
The FDA issued a Class II for N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IV by SIEMENS HEALTHCARE DIAGNOSTICS INC. Reason: 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.
Details
Source
Device Recall
External ID
Z-0094-2023
Action Date
2022-10-26
Status
Ongoing
Category
device
Product Description
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Lot/Code Info: UDI-DI: 0405686900179VF Lot Number: 153083; 153085; 153087A; 153090; 153095B; 153099A; 153004B. Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package
Quantity Affected: 10,201 packs
Reason for Recall
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).
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-30
Company
Tarrytown, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SIEMENS HEALTHCARE DIAGNOSTICS INC has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SIEMENS HEALTHCARE DIAGNOSTICS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SIEMENS HEALTHCARE DIAGNOSTICS INC have FDA actions?
SIEMENS HEALTHCARE DIAGNOSTICS INC has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0094-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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