FDAClass IIJuly 10, 2019

VITROS 250 Chemistry System recall

VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and…

Why was VITROS 250 Chemistry System recalled?

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

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?

All lots

Product
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and…
Recalling firm
Ortho-Clinical Diagnostics
Quantity
5020 units
Distribution
US Nationwide Distribution
Recall date
July 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls