Recall Z-1936-2019
Ortho-Clinical Diagnostics · initiated April 8, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All lots
Reason for recall
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
FDA-determined 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.
Details
- Recall number
- Z-1936-2019
- Initiated
- April 8, 2019
- Terminated
- November 12, 2020
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 3889 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1933-2019 Class II | VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage:…Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. | 04/08/2019Terminated |
| Z-1934-2019 Class II | VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product…Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. | 04/08/2019Terminated |
| Z-1935-2019 Class II | VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330)…Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. | 04/08/2019Terminated |