Rochester, NY, United States
Clinical Diagnostic Systems recalls
1 recall recorded since 2018, most recently on 11 January 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 11 January 2018
- Terminated
- 8 September 2020
- Reason
- VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
- Distribution
- Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1322-2018
- VITROS Immunodiagnostic Products TSH Reagent Pack
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.