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Serious recall: Injury is possible or has been reported. Take action promptly.

Siemens Healthcare Diagnostics, Inc. 2024-09-18 Health serious FDA
Health · FDA · Recall #FDA-Z-3063-2024

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

Issued September 18, 2024 · Siemens Healthcare Diagnostics, Inc.

In September 2024, Siemens Healthcare Diagnostics, Inc. recalled the Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN):…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

What you should do

  1. 1 Stop using Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN):… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Siemens Healthcare Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Siemens Healthcare Diagnostics, Inc.
Category
Health
Recall date
September 18, 2024
Units affected
Not reported
Sold at
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 Aust
Recall number
FDA-Z-3063-2024
Made in
United States
Issuing agency
FDA

In context

Read the official FDA notice

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