FDA recall Z-0770-2021

Ortho Clinical Diagnostics Inc · Class II · device

Product

VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

Reason for recall

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore 609917, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.

Key facts

Status: Ongoing
Initiation date: 2020-12-11
Report date: 2021-01-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0770-2021