IRISpec" CA/CB two-part urine chemistry control twin set — Class III medical device recall Z-2124-2012
Terminated recall by Iris Diagnostics, reported 2012-08-08, distributed nationwide. The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, w
| Recall number | Z-2124-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iris Diagnostics, Chatsworth, CA, United States |
| Recall initiated | 2012-07-09 |
| Classified | 2012-08-01 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2014-01-27 |
| Distributed | Nationwide (US) |
| Quantity | 862 |
| Lot numbers | 131-12 |
| Model numbers | 800-0074 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2124-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.