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

Recall Z-1523-2016 — Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antib

U.S. FDA — Device Enforcement · United States · 2016-03-31 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1523-2016
Date of alert: 2016-03-31
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Biocare Medical, LLC
Product category: device
Product type: Devices

Reported risk: Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer.

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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