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

Recall Z-2392-2012 — Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or he

U.S. FDA — Device Enforcement · United States · 2012-08-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2392-2012
Date of alert: 2012-08-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Instrumentation Laboratory Co.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 09120101

Reported risk: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

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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