SIEMENS HEALTHCARE DIAGNOSTICS INC N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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).

Recommended Action

Per FDA guidance

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.