Z-1003-2024Class II

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Name: Z-1003-2024 Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-12-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-12-15 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry on 2023-12-15. FDA classified it as Class II and gives the reason as "Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1003-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-15
Posted: 2024-02-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Reason for recall: Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter dated 12/19/23 was sent to customers. Actions to be Taken by the Customer: Siemens Healthineers recommends batch testing samples for Atellica CH IgM_2 as follows: 1. Remove and discard any Atellica CH IgM_2 reagent packs onboard the analyzer. 2. Load a single fresh Atellica CH IgM_2 reagent pack onto the analyzer. 3. Perform a Lot calibration and process Quality Control (QC). 4. Immediately process a batch of patient samples and conclude with a repeat run of QC. Patient results should not be reported until the QC performed at the end of the batch run has been assessed. - If the QC results are within the established range, patient results can be reported. - If the QC results are not within the established range, do not report patient results and repeat steps 1 4 above. 5. Remove and discard the Atellica CH IgM_2 reagent pack at the end of the batch run. Siemens Healthineers does not recommend using the ADVIA IgM_2 reagent on the Atellica CH or Atellica CI Analyzers. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 7,075 units (927 US, 6148 OUS)
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and PR; The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Curacao, Czech Republic, Denmark, Egypt, Estonia, Finland France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kenya, Kuwait, Latvia, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom, Uruguay, Vatican City, Vietnam, Zaire.
Product codes and lots: Siemens Material Number (SMN): 11097620; UDI DI: 00630414595627; Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), 232025 (11/01/2024).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1003-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1003-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-07

Product code CFN

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)