FDA-Device2012-08-08Class III
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.
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.
Sold states
Nationwide Distribution
Affected count
862
Manufactured in
9172 Eton Ave, N/A, Chatsworth, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2124-2012Don't want to check this manually?
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