Recall Z-2202-2019— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2019-06-17, terminated 2020-11-09. It names 2 FDA 510(k) clearances: K182072, K955286. Product: VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems. Reason: Potentially Biased Results using VITROS Chemistry Products GLU Slides.
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-17
- Terminated
- 2020-11-09
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
- K955286 — EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
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 GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Reason for recall
Potentially Biased Results using VITROS Chemistry Products GLU Slides
Data sourced from openFDA. This site is unofficial and independent of the FDA.