Recall Z-2124-2012 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Iris Diagnostics
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.
| Date | Aug 1, 2012 (initiated Jul 9, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the rec |
| Quantity | 862 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945913 | IRISPEC URINE CHEMISTRY CONTROL PART A AND B International Remote Imaging Systems, Apr 5, 1995 |