FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin REF: 11537225
- Recall number
- Z-2890-2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Urine Albumin REF: 11537225
- Status
- Open, Classified
- Initiated
- 2026-07-06
- Posted
- 2026-08-05
- Terminated
- not on file
- 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. 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.
- 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, 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.¿
- Lot, serial or model codes
- All Lots within expiry/UDI: 00630414611099
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIR
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28