Recall Z-0093-2023— SIEMENS HEALTHCARE DIAGNOSTICS INC

Name: FDA recall Z-0093-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-30

Class II · Ongoing

Class II FDA medical device recall by SIEMENS HEALTHCARE DIAGNOSTICS INC, initiated 2022-08-30. It names one FDA 510(k) clearance: K083445. Product: N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297. 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)..

Recalling firm: SIEMENS HEALTHCARE DIAGNOSTICS INC
Classification: Class II
Status: Ongoing
Initiated: 2022-08-30
Firm location: Tarrytown, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

K083445 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LCSiemens Healthcare Diagnostics·cleared 2009-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.