Recall Z-0651-2019— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-10-19, terminated 2022-01-24. It names one FDA 510(k) clearance: K063144. Product: VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.. Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-19
- Terminated
- 2022-01-24
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Reason for recall
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Data sourced from openFDA. This site is unofficial and independent of the FDA.