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Recall Observatory FDA recall evidence

Device product

Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.

Z-0110-2016

August 31, 2015

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 72090
Status
Terminated
Classification
Class II
Quantity
16,648 units total (1874 units in US)
Official record key
device-enforcement:Z-0110-2016

Official wording

Reason: Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.

Code information: Lot: 431433

Distribution pattern: Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.