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Recall Observatory FDA recall evidence

Device product

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

Z-2573-2018

January 05, 2018

Class III

Product summary

Firm
Diamedix Corporation
Event
Event 80441
Status
Terminated
Classification
Class III
Quantity
505
Official record key
device-enforcement:Z-2573-2018

Official wording

Reason: Contains a gel-like contaminant that may affect product performance.

Code information: Lot S0406 Exp. 05/31/2018

Distribution pattern: AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Contains a gel-like contaminant that may affect product performance.