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Recall Observatory FDA recall evidence

Device product

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above

Z-1308-2023

February 01, 2023

Class II

Product summary

Firm
Quidel Corporation
Event
Event 91772
Status
Ongoing
Classification
Class II
Quantity
771 units
Official record key
device-enforcement:Z-1308-2023

Official wording

Reason: Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

Code information: UDI: 30014613335580; Lot Number: 213783

Distribution pattern: not yet available

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.