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Terminated

MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

FDA Recall Z-1499-2018 · Posted None

Recalling FirmDiagnostic Hybrids, Inc.
Recall StatusTerminated
Product CodeN/A
Date Initiated2015-11-03
Date Terminated2020-08-28
Product Quantity72 kits

Reason for Recall

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

Firm Action

Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.

Root Cause

Material/Component Contamination

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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