Recall Z-1237-2007 ยท MRG System, Test, Vitamin D
Diasorin Inc.
25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
| Date | Sep 20, 2007 (initiated Aug 21, 2007) |
| Status | Terminated |
| Reason | 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer. |
| Root cause | Other |
| Action | Consignees were notified by phone on 8/21/07 followed by a written notification by Fax or email. The letter described the product and problem and recommended to inspect the kits and to destroy all tracer vials of lot number 726023. They also requested the consignee to return the findings by fax or mail. |
| Quantity | 117 kits |
| Distribution | Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA Incstar Corp., Sep 25, 1996 |