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

Recall Z-1948-2013 — Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3

U.S. FDA — Device Enforcement · United States · 2013-06-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1948-2013
Date of alert: 2013-06-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ortho-Clinical Diagnostics
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 34000133

Reported risk: Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.

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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