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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
Recall Number Z-2124-2012
Classification Class III
Code Info Iris Diagnostics part number 800-0074, lot number 131-12.
Product Distributed Qty 862
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.

Event Detail

Event Id 62555
Product Type Devices
Status Ongoing
Recalling Firm Iris Diagnostics
City Chatsworth
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
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