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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1240-2008
Recalling firm
Diasorin Inc.
Product
LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082
Status
Terminated
Initiated
2008-02-01
Posted
2008-05-07
Terminated
2008-10-31
Reason
Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
Root cause
Nonconforming Material/Component
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.
Quantity
2,267 kits
Distribution
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.
Lot, serial or model codes
Lot Numbers: 120422 and 120423.
510(k) numbers
["K032844"]
PMA numbers
not on file
Product code
MRG
Firm FEI
2182595
Firm city
Stillwater
Firm state
MN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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