Z-1237-2007

25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285...

Name: Z-1237-2007 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285...
Creator: Diasorin Inc.
Published: 2007-08-21
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2007-08-21 / Terminated

FDA source

Diasorin Inc. began a recall of 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A on 2007-08-21. The reason FDA records is "25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1237-2007
Status: Terminated
Initiated: 2007-08-21
Posted: 2007-09-20
Terminated: 2008-10-17
Recalling firm: Diasorin Inc.
Product: 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
Product code: MRG System, Test, Vitamin D
Reason for recall: 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.
FDA 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 in commerce: 117 kits
Distribution: Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.
Product codes and lots: Part # 68100E, lot # 119604A

Product code MRG

K953567Class IIIncstar 25-Hydroxyvitmin D 1251 RiaIncstar Corp. / cleared 1996-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)