FDA Enforcement
Class III
Terminated
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.
Recall: Z-2124-2012
·
Reported August 8, 2012
Enforcement
- Recall Number
- Z-2124-2012
- Event ID
- 62555
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Iris Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 8, 2012
- Initiation Date
- July 9, 2012
- Classification Date
- August 1, 2012
- Termination Date
- January 27, 2014
- Address
- 9172 Eton Ave, N/A, Chatsworth, CA, 91311-5805, United States
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
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 Info
Iris Diagnostics part number 800-0074, lot number 131-12.
Distribution
Nationwide Distribution
Quantity
862