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
Reported: August 14, 2019 Initiated: June 17, 2019 #Z-2202-2019
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
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 1099 (5 pack x 60)=329700 slides
- Distribution
- US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ortho-Clinical Diagnostics. Units affected: 1099 (5 pack x 60)=329700 slides.
Why was this product recalled? ▼
Potentially Biased Results using VITROS Chemistry Products GLU Slides
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2202-2019.
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