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Iris Diagnostics recalls IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpe
Recalled August 8, 2012 · FDA recall Z-2124-2012 · Iris Diagnostics
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. · FDA Class III
Units
862
Sold at
Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Iris Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →