—#180693

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.

FDA product code: JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K861387
Affected lot / code info: CKMB Slides that expire after July 20, 2018 and within current expiry.

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 513 Technology Blvd, Rochester, New York 14626-3601

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-04-01
Terminated: 2021-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180693. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.