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Terminated

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

FDA Recall Z-1237-2007 · Posted 2007-09-20

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMRG
Date Initiated2007-08-21
Date Terminated2008-10-17
Product Quantity117 kits

Reason for Recall

25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953567INCSTAR 25-HYDROXYVITMIN D 1251 RIAIncstar Corp. · 1996-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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