Recall Z-0911-2018— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2017-09-22, terminated 2020-08-24. It names 2 FDA 510(k) clearances: K062165, K062077. Product: VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic. Reason: This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-22
- Terminated
- 2020-08-24
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K062165 — VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
- K062077 — VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
K-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 Chemistry Products DAT Performance Verifier I in vitro diagnostic
Reason for recall
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Data sourced from openFDA. This site is unofficial and independent of the FDA.