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 t
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics Inc. is recalling VITROS Chemistry Products CKMB Slides in two configurations: the 60-slide cartridge (Product Code 8058232) and the 18-slide cartridge (Product Code 8001133). The recall affects 41,598 units total, with 403 units distributed in the United States and 41,195 units distributed internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and The Netherlands. The recalled products are associated with coating lots 0230, 0231, 0233, 0235, 0239, 0245, 0246, 0248, and 0261.
The reason for the recall is a potential for falsely elevated results due to CK-MM interference in the CKMB slide testing. The initial communication about this recall was issued on December 11, 2020, with four subsequent recall extensions announced between June 2021 and October 2023. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
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. Quantity: Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.