FDAClass IIAugust 14, 2019

VITROS Chemistry Products GLU Slides-Product recall

VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration…

Why was VITROS Chemistry Products GLU Slides-Product recalled?

Potentially Biased Results using VITROS Chemistry Products GLU Slides

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572

Product
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration…
Recalling firm
Ortho-Clinical Diagnostics
Quantity
1099 (5 pack x 60)=329700 slides
Distribution
US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
Recall date
August 14, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls