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

Recall Z-0563-2013 — CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performanc

U.S. FDA — Device Enforcement · Denmark · 2012-11-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0563-2013
Date of alert: 2012-11-26
Country / jurisdiction: Denmark
Risk level: Class II
Risk type: recall
Brand: Dako Denmark A/S
Product category: device
Product type: Devices

Reported risk: The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.

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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