FDAClass IIAugust 14, 2019

Dimension¿ Ferritin recall

Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL…

Why was Dimension¿ Ferritin recalled?

Negative Bias with Lot EA9227.

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?

Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840

Product
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
815 kits
Distribution
Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS MT NC NE NH NJ NY OK OR PR SD TN TX VA VT WA WI
Recall date
August 14, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls