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

Recall Z-2087-2012 — PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categorie

U.S. FDA — Device Enforcement · United States · 2011-12-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2087-2012
Date of alert: 2011-12-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Tripath Imaging, Inc.
Product category: device
Product type: Devices

Reported risk: Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.

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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