Ortho VITROS CKMB Slides Recalled for Potential Falsely Elevated Results
Ortho Clinical Diagnostics is recalling VITROS CKMB Slides because CK-MM interference may cause falsely elevated creatine kinase MB results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic errors (falsely elevated results) rather than direct physical injury or contamination, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling VITROS Chemistry Products CKMB Slides, including 60-slide and 18-slide cartridges, due to a potential for falsely elevated results. The issue is caused by interference from CK-MM, which can affect the quantitative measurement of creatine kinase MB (CK-MB) activity in serum.
The recall covers specific product codes 8058232 and 8001133 used with VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems. The initial communication was issued on December 11, 2020, and the recall has been extended multiple times to include additional coating lot numbers, with the most recent extension occurring on October 27, 2023.
The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Brazil, Canada, and the United Kingdom. Users of these diagnostic slides should contact Ortho Clinical Diagnostics for instructions on how to proceed with the recall and replacement of the affected units.
The recalled product
- 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…
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distributed nationwide across the United States.
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