ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)… recallZ-2451-2023 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 25, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

An Urgent Medical Device Correction dated 7/25/23 was sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Perform the instructions provided in Additional Information. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Recall details

Recall number: Z-2451-2023
Status: Open, Classified
Initiated by the company: Jul 25, 2023
Posted by the FDA: Aug 24, 2023
Recalling firm: Siemens Healthcare Diagnostics, Inc.
Quantity: 3067 units
Product code: JIT
Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distribution.

Product description

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid

Code information (models, lots, serial numbers)

UDI-DI: 00630414279176; Lot Numbers: All lots

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

ADVIA Chemistry UCFP 11319151
Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN
2 recalls10 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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