Product Wiki · Recalls · U.S. FDA — Device Enforcement

IRISpec" CA/CB two-part urine chemistry control twin set, Iris… — recall Z-2124-2012

U.S. FDA — Device Enforcement · United States · 2012-07-09 · Class III

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2124-2012
Date of alert
2012-07-09
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Iris Diagnostics
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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