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Terminated

STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France

FDA Recall Z-0812-2007 · Posted 2007-05-16

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGKP
Date Initiated2007-01-18
Date Terminated2007-12-10
Product Quantity693 units

Reason for Recall

Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

Firm Action

A recall notification has not been sent. The firm did issue a technical bulletin to their representatives.--Update: based on FDA input the firm issued a Recall Letter to all users dated May 25, 2007

Root Cause

Other

Distribution Pattern

Product was distributed to hospitals and laboratories nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961579STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZERAmerican Bioproducts Co. · 1996-07-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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