Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1496-2018 — MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples a

U.S. FDA — Device Enforcement · United States · 2017-04-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1496-2018
Date of alert: 2017-04-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Diagnostic Hybrids, Inc.
Product category: device
Product type: Devices

Reported risk: There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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