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

Recall Z-1461-2020 — Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls * CAT. No.: C2003-2 * Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the R

U.S. FDA — Device Enforcement · Canada · 2019-03-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1461-2020
Date of alert: 2019-03-15
Country / jurisdiction: Canada
Risk level: Class II
Risk type: recall
Brand: Response Biomedical Corp.
Product category: device
Product type: Devices

Reported risk: The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.

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

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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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