Z-0094-2023Class II

N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number...

Name: Z-0094-2023 N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2022-08-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-08-30 / Open, Classified

FDA source

SIEMENS HEALTHCARE DIAGNOSTICS INC began a recall of N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299 on 2022-08-30. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0094-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-30
Posted: 2022-10-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
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 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 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: 10,201 packs
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0094-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0093-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14
Z-0094-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14

Product code CFN

K083445Class IIN Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/t Protein Control LcSiemens Healthcare Diagnostics / cleared 2009-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)