Recall Z-2344-2018— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-05-09, terminated 2020-08-18. It names 2 FDA 510(k) clearances: K081543, K941142. Product: VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic. Reason: There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-09
- Terminated
- 2020-08-18
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K081543 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
- K941142 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
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 PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Reason for recall
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
Data sourced from openFDA. This site is unofficial and independent of the FDA.