Recall Z-0599-2025 ยท JZG System, Test, Beta-2-Microglobulin Immunological
Siemens Healthcare Diagnostics, Inc.
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
| Date | Dec 4, 2024 (initiated Oct 21, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| 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 Interv |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.