Z-1930-2020Class II

VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number...

Name: Z-1930-2020 VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number...
Creator: Ortho-Clinical Diagnostics
Published: 2020-04-01
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-04-01 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry... on 2020-04-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1930-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-01
Posted: 2020-05-08
Terminated: 2021-01-19
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Reason for recall: 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 tag: labeling and UDI
FDA 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.
Distribution: US Nationwide distribution.
Product codes and lots: CKMB Slides that expire after July 20, 2018 and within current expiry.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1930-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1930-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08
Z-1931-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code JHS

K861387Class IIKodak Ektachem Clinical Chemistry Slides (Ck-Mb)Eastman Kodak Company / cleared 1986-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)