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

Recall Z-0815-2016 — CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in i

U.S. FDA — Device Enforcement · United States · 2016-01-18 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0815-2016
Date of alert: 2016-01-18
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Lab Vision Corporation
Product category: device
Product type: Devices

Reported risk: Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.

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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