FDAClass IIOctober 17, 2018

VITROS 5600 Integrated System-For use in the in vitro recall

VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of…

Why was VITROS 5600 Integrated System-For use in the in vitro recalled?

Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

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?

Serial Numbers : J56000024 through J56003300

Product
VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of…
Recalling firm
Ortho-Clinical Diagnostics
Quantity
U.S.= 1255 ex-U.S.= 1504
Distribution
Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Recall date
October 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls