Z-0599-2025Class II

Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of...

Name: Z-0599-2025 Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-10-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-10-21 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma. Siemens Material... on 2024-10-21. FDA classified it as Class II and gives the reason as "Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0599-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-21
Posted: 2024-12-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
Product code: JZG System, Test, Beta-2-Microglobulin Immunological
Reason for recall: Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.
FDA root cause: Under Investigation by firm
Action: Siemens issued Urgent Medical Device Correction (UMDC) ACHC25-02.A.US was issued to US affected customers by FedEx beginning on 10/28/2024 and Urgent Field Safety Notice (UFSN) ACHC25-02.A.OUS. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " Manually dilute patient samples that are > 18.00 mg/L: 1. Navigate to the CH Test Definition screen. 2. Under Measuring Interval, uncheck Repeat when Outside Measuring Interval. 3. For samples that generate test results > 18.00 mg/L, prepare a 1:2 manual dilution with saline solution (0.9% unbuffered Isotonic saline). 4. From the Create Patient Order screen, order the sample and enter 2 in the manual dilution field on the left of the screen. Note: The system will apply the 1:2 dilution factor and calculate the final result. 5. Process the manually diluted sample. "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. Resolution The Atellica CH B2M assay IFU will be updated with the above steps to support manual 1:2 dilution only with saline for samples > 18.00 mg/L. Please see Appendix, Table 2, for data using these revised instructions. Contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 11330 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait, Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zaire.
Product codes and lots: UDI-DI: 00630414595566 All in-date and future Atellica CH B2M reagent lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0599-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0599-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04

Product code JZG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)