FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
- Recall number
- Z-1930-2020
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
- Status
- Terminated
- Initiated
- 2020-04-01
- Posted
- not on file
- Terminated
- 2021-01-19
- Reason
- The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
- Root cause
- Labeling design
- Action
- An Urgent Product Correction letter was sent on April 1, 2020 to affected customers stating that the Spanish and Swedish IFU versions for the VITROS CK-MB slides incorrectly included plasma as a sample type in the Intended Use section. Customers were instructed to complete and return the Confirmation of Receipt form then, determine whether the effected IFUs were being used in their laboratory and identify any plasma samples that were taken while using those instructions for use. The laboratory directors should determine how to handle the assays that used plasma samples. The firm directed customers to go to the Ortho-Clinical Diagnostics website to download the updated Spanish and Swedish IFUs.
- Quantity
- not on file
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- CKMB Slides that expire after July 20, 2018 and within current expiry.
- 510(k) numbers
- ["K861387"]
- PMA numbers
- not on file
- Product code
- JHS
- Firm FEI
- 1000305840
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28