VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Cod...
FDA Recall #Z-0770-2021 — Class II — December 11, 2020
Product Description
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
Recalling Firm
Ortho Clinical Diagnostics Inc — Raritan, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units
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.
Code Information
INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302) Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) Extended Recalls: Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021 Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication Reference, CL2021-214) 18 August 2021 Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication Reference, CL2021-274) , 1 November 2021 Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication Reference, CL2023-244) , 27 October 2023 UDI: (1) (10758750004294) (2) (10758750004201
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated