Recall Z-2890-2026 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urine Albumin REF: 11537225
| Date | Aug 5, 2026 (initiated Jul 6, 2026) |
| Status | Open, Classified |
| Reason | processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures. |
| Root cause | Under Investigation by firm |
| Action | On July 6, 2026, Siemens Healthineers issued a Urgent Medical Device Recall to affected consignees via Fed Ex. Siemens Healthineers ask consignees to take the following actions: 1. Discontinue Atellica CH Urine Albumin (UAlb) testing and transition to the Atellica CH Microalbumin_2 (ALB_2) reagent, SMN 11097610, and Atellica CH Microalbumin_2 Calibrator (ALB_2 CAL), SMN 11099435, as an alternate test solution. 2. Replace all reaction cuvette segments following discontinuation of UAlb testing. Refer to the Atellica Solution Online Help for instructions on replacing reaction cuvette segments. |
| Quantity | 7018 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Australia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.