Device 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.
Z-2124-2012
Product summary
- Firm
- Iris Diagnostics
- Event
- Event 62555
- Status
- Terminated
- Classification
- Class III
- Quantity
- 862
- Official record key
device-enforcement:Z-2124-2012
Official wording
Reason: 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.
Code information: Iris Diagnostics part number 800-0074, lot number 131-12.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.