FDA Medical devices recall · September 17, 2025

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) recall

Read the official FDA notice ↗

Product

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

Why was it recalled?

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.

States: Georgia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2542-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.