Z-2451-2023Class II

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use...

Name: Z-2451-2023 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-07-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-07-25 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total... on 2023-07-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2451-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-25
Posted: 2023-08-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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
Product code: JIT Calibrator, Secondary
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 3067 units
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 codes and lots: UDI-DI: 00630414279176; Lot Numbers: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2451-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2451-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24

Product code JIT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)