FDAClass IIMarch 22, 2017

VITROS Chemistry Products Li recall

VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog…

Why was VITROS Chemistry Products Li recalled?

Intermittent imprecision in results generated using two specific lots of VITROS Li 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?

REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01

Product
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog…
Recalling firm
Ortho-Clinical Diagnostics
Quantity
US: 94 sales units; OUS: 136 sales units
Distribution
US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls