Enforcement Report - Week of August 8, 2012
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Event Detail
| Event ID | 62555 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Iris Diagnostics |
| City | Chatsworth |
| State | CA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Iris Diagnostics part number 800-0074, lot number 131-12. | Class III | 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. | 862 | Z-2124-2012 |
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