CLASS III Device recall · Reported 8 Aug 2012 · FDA Enforcement Report
IRISpec" CA/CB two-part urine chemistry control twin set recalled
Iris Diagnostics is recalling IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics, distributed nationwide in the US. The recall was initiated on 9 Jul 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2124-2012
- FDA event ID
- 62555
- Recalling firm
- Iris Diagnostics, Chatsworth, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Jul 2012
- FDA classified
- 1 Aug 2012
- Reported
- 8 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Patient Monitors
Timeline
| 9 Jul 2012 | Recall initiated by company | |
| 1 Aug 2012 | Classified by FDA | +23 days |
| 8 Aug 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Iris Diagnostics part number 800-0074, lot number 131-12.
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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