FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
- Recall number
- Z-0181-2022
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
- Status
- Open, Classified
- Initiated
- 2021-09-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
- Root cause
- Software design
- Action
- On September 20, 2021, the firm distributed Urgent Medical Device Correction letters to impacted customers. Atellica customers were informed that the resolution of the issue will be implemented in SW v1.25.1. ADVIA customers were informed that the resolution of the issue will be implemented in AP Tool v1.11 and TDef v.1.07. These updates will be available soon. In the interim, customers were provided additional instructions to work around the issue until the update is available. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
- Quantity
- 246 (US); 689 (OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Lot, serial or model codes
- All lots impacted
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CEK
- 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