Z-0440-2022Class II

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

Name: Z-0440-2022 Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-12-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-12-01 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma Siemens... on 2021-12-01. FDA classified it as Class II and gives the reason as "2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0440-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-01
Posted: 2021-12-29
Terminated: 2023-07-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH 2-Microglobulin (B2M) -M) Assay for 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: 2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
FDA root cause: Under Investigation by firm
Action: Siemens issued An Urgent Medical Device Correction (UMDC) letter to US customers by FedEx beginning on 2021-12-01. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 2021-12-01. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the kit lot listed in Table 1. Review your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please review this letter with your Medical Director. 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 product 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. If you have any questions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: US: 46 units OUS: 794 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.
Product codes and lots: Lot Number: 211446 UDI: 00630414595566

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0440-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0440-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-05	2021-12-29

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)