Recall Z-0093-2023 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
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
| Date | Oct 14, 2022 (initiated Aug 30, 2022) |
| Status | Open, Classified |
| 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 (CSF). |
| Root 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 Hu |
| Quantity | 373 PCK |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083445 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC Siemens Healthcare Diagnostics, Mar 24, 2009 |