Z-3063-2024Class II

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

Name: Z-3063-2024 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-07-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-07-29 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 on 2024-07-29. FDA classified it as Class II and gives the reason as "The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3063-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-29
Posted: 2024-09-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Product code: CEK Biuret (Colorimetric), Total Protein
Reason for recall: The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
FDA root cause: Under Investigation by firm
Action: On July 29, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Impact to Results Erroneously depressed or elevated urine protein or cerebrospinal fluid patient results may occur. Siemens investigation revealed a positive bias of up to 52% (at 27.3 mg/dL (273 mg/L); up to 19% at 68.7 mg/dL (687 mg/L)). However, analyte recovery decreases rapidly after opening a reagent pack and a negative bias of up to -35% was observed at 24 hours (at 27 mg/dL (270 mg/L); up to -9% at 67 mg/dL (670 mg/L)). Results of this assay would be interpreted in conjunction with the patient s medical history, clinical presentation, and other findings. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Discontinue use of and discard the kit lot listed in the table above (Products Section). 3. Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. 4. 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: 1,164 units (229 US, 935 OUS)
Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, India, Ireland, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E., United Kingdom, Uruguay, Vatikancity.
Product codes and lots: Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3063-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3063-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3064-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06

Product code CEK

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)