—#172700

Product

VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K922072
Affected lot / code info: All lots

Why it was recalled

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Root cause (FDA determination)

Device Design

Action the firm took

On 08 April 2019, a customer letter (Ref. CL2019-090) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) to either all customers who were shipped affected VITROS 250 or 350 Systems. This communication provided the following required actions: - As per the VITROS CK Slide Instructions for Use, perform Quality Control (QC) testing daily to help ensure the slides are performing within acceptable limits. - If QC results are outside of the established ranges, discard the cartridge and repeat QC testing using a fresh cartridge of VITROS CK Slides. - If multiple cartridges are loaded on the VITROS 250/350 System, daily QC testing must be performed for each cartridge prior to use. - Consider loading one cartridge of VITROS CK Slides on board your system at a time. - Complete and return the request form via fax to 1-888-557-3759. Foreign affiliates were informed by email on 08 April 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2019-04-08
Terminated: 2020-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172700. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.