FDAFDA · Food and drugs·Recall number Z-2124-2012
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.
Published August 8, 2012 · Recall initiated: July 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Iris Diagnostics
- Distributor
- Nationwide Distribution
- Lot
- Iris Diagnostics part number 800-0074, lot number 131-12.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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