Recall Z-0884-05 ยท JJW Urinalysis Controls (Assayed And Unassayed)
International Remote Imaging Systems Inc
IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
| Date | Jun 11, 2005 (initiated Apr 29, 2005) |
| Status | Terminated |
| Reason | Nonconformance to performance specifications. |
| Root cause | Other |
| Action | Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005. |
| Quantity | 107 |
| Distribution | Nationwide. |
| 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 |