Recall Z-0705-05 ยท LCI Automated Radioimmunoassay Systems, For Clinical Use
Diasorin Inc.
DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 113300B.
| Date | Apr 13, 2005 (initiated Jun 30, 2004) |
| Status | Terminated |
| Reason | An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18. |
| Root cause | Other |
| Action | A customer notification letter was sent to customers 6/30/04. The letter identified theproduct, problem and the correct expiration date. Customers were instructed to complete the response form on the lower portion of the notification and fax it back to DiaSorin. |
| Quantity | 181 |
| Distribution | MI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983617 | 25-HYDROXYVITAMIN D 125I RIA KIT DiaSorin, Inc., Nov 16, 1998 |