FDAClass IIMay 30, 2018

iChem VELOCITY Automated Urine Chemistry System recall

iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog…

Why was iChem VELOCITY Automated Urine Chemistry System recalled?

The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.

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 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.

Product
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog…
Recalling firm
Beckman Coulter Inc.
Quantity
6 devices
Distribution
US Distribution to states of: AL, IA, GA, and FL.
Recall date
May 30, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls