FDAClass IIMay 23, 2018

iChem VELOCITY Urine Chemistry Strips recall

iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice…

Why was iChem VELOCITY Urine Chemistry Strips recalled?

A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.

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?

Lot #7212154 A

Product
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice…
Recalling firm
Beckman Coulter Inc.
Quantity
14340 units
Distribution
Worldwide Distribution and US Nationwide Distribution
Recall date
May 23, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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