device · product 1 of 1
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.
- Recall number
- Z-0770-2021
- Initiated
- December 11, 2020
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Quantity
- Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units
App-derived interpretation
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
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
Distribution pattern
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.