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Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) recallZ-3063-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 29, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-3063-2024
Status
Open, Classified
Initiated by the company
Jul 29, 2024
Posted by the FDA
Sep 6, 2024
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1,164 units (229 US, 935 OUS)
Product code
CEK
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 description

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

Code information (models, lots, serial numbers)

Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 95112).

Sources and updates

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