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Terminated

LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082

FDA Recall Z-1240-2008 · Posted 2008-05-07

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMRG
Date Initiated2008-02-01
Date Terminated2008-10-31
Product Quantity2,267 kits

Reason for Recall

Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.

Firm Action

Consignees were notified by a Diasorn Customer Notification Letter sent by email on 2/1/08. The letter instructs users to stop using the affected kits, destroy any kits remaining in inventory and to return a response form in order to receive replacement product. For additional information contact 1-800-328-1482.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution including USA states of AR, CA, GA, IA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OR, PA, TN, UT and WA and country of Austria.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032844LIAISON 25 OH VITAMIN DDiaSorin, Inc. · 2004-02-12

Official Source

View FDA Recall →

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

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