Recall Z-2124-2012— Iris Diagnostics
Class III · Terminated
Class III FDA medical device recall by Iris Diagnostics, initiated 2012-07-09, terminated 2014-01-27. It names one FDA 510(k) clearance: K945913. 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.. 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..
- Recalling firm
- Iris Diagnostics
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-07-09
- Terminated
- 2014-01-27
- Firm location
- Chatsworth, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.