Class 2 Device Recall Siemens N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

• Date Initiated by Firm: August 30, 2022
• Date Posted: October 14, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0093-2023
• Recall Event ID: 90867
• 510(K)Number: K083445
• Product Classification: Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
• Product: N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD; Siemens Material Number (SMN): 10446297
• Code Information: 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
• Recalling Firm/ Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 Benedict Ave; Tarrytown Spain
• Manufacturer 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).
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction (UMDC) PP-22-003-A-C US to US customers by FedEx on 08/30/2022; and Urgent Field Safety Notice (UFSN) PP-22-003-A-C OUS -all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 08/19/2022. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Discontinue use of N Antiserum to Human IgG lot 153095B for urine and CSF sample determination. However, the N Antiserum to Human IgG lot 153095B can still be used for serum sample determination. All other N Antiserum to Human IgG lots listed in Table 1 can continue to be used with the following new preliminary high dose hook thresholds for urine and CSF: " Urine: 395 mg/L " CSF: 412 mg/L Further information regarding establishment of the preliminary high dose hook threshold can be found within section Additional Information . " The specified high dose hook threshold for serum (83.3 g/L) remains unchanged for all N Antiserum to Human IgG lots. According to the IFU, in case of questionable results, the determinations should be repeated using the next higher sample dilution. For patient monitoring, consecutive immunoglobulin determinations should be performed from the same sample dilution, as far as possible. Review your inventory of the N Antiserum to Human IgG lot 153095B to determine your laboratory s replacement needs, if required, and to provide information to Siemens Healthineers for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
• Quantity in Commerce: 373 PCK
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CFN and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS