Z-2124-2012 Class III Terminated
FDA device recall Z-2124-2012 was initiated by Iris Diagnostics on July 9, 2012 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated January 27, 2014). Affected quantity: 862.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2012
- Initiation Date
- July 9, 2012
- Termination Date
- January 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 862
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
Iris Diagnostics part number 800-0074, lot number 131-12.