FDAClass IIJune 7, 2023

VITROS Chemistry Products Calibrator Kit 11 VANC recall

VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215…

Why was VITROS Chemistry Products Calibrator Kit 11 VANC recalled?

Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023

Product
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215…
Recalling firm
Ortho-Clinical Diagnostics, Inc.
Quantity
132 units
Distribution
Nationwide Foreign: Brazil, Chile, Colombia
Recall date
June 7, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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