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

Recall Z-1906-2019 — EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

U.S. FDA — Device Enforcement · United States · 2019-01-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1906-2019
Date of alert
2019-01-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bio-Rad Laboratories, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
03610520562024
Reported risk: User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).
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.

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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.