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Recall Observatory FDA recall evidence

Device product

MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

Z-1498-2018

November 03, 2015

Class III

Product summary

Firm
Diagnostic Hybrids, Inc.
Event
Event 79642
Status
Terminated
Classification
Class III
Quantity
107 kits
Official record key
device-enforcement:Z-1498-2018

Official wording

Reason: A component of the kit was found to contain bacterial contamination.

Code information: Lot 052418

Distribution pattern: Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination