IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec C

FDA device recall Z-2124-2012 · posted 2012-08-01 · Terminated

Recall details

Recalling firm

Iris Diagnostics

Reason for recall

The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.

Action taken

The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the recall was also provided. The communications also included a fax response sheet for return/replacement.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJW

Quantity affected

862

Distribution

Nationwide Distribution

Date initiated

2012-07-09

Date posted

2012-08-01

Date terminated

2014-01-27

Location

Chatsworth, CA

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