Official recall record
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determina
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-07-25
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00630414279176
- Brand on record
- Siemens Healthcare Diagnostics, Inc.
What the authority reported
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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All 38 official recall notices naming Siemens Healthcare Diagnostics, Inc. on this site →
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