Recall StatusOpen, Classified
Date Initiated2026-07-06
Product Quantity7018 units
Reason for Recall
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.
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.
3. Complete the Field Correction Effectiveness Check Form attached to this letter and return
within 30 days.
4.Credit will be issued for unexpired UAlb reagent (SMN 11537225), UAlb calibrator (SMN
11537247), and reaction cuvettes segments, as applicable.
5. Please review this letter with your Medical Director to determine the appropriate course
of action, including whether review of any previously generated results is warranted.
6. Please retain this letter with your laboratory records and forward this letter to those who
may have received the affected product.
Root Cause
Under Investigation by firm
Distribution Pattern
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, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Cura¿ao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.