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.
This recall has been terminated (originally issued April 8, 2019).
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- April 8, 2019
- Terminated
- November 12, 2020
- Recall Number
- Z-1936-2019
- Quantity
- 3889 units
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Distribution
US Nationwide Distribution
Lot / Code Info
All lots
Root Cause
Device Design
Action Taken
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.