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Terminated

MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

FDA Recall Z-0297-05 · Posted 2004-12-08

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNPQ
Date Initiated2004-11-05
Date Terminated2005-08-29
Product Quantity65

Reason for Recall

Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.

Firm Action

Consignees were notified via letter dated 11/5/04, which provides the user with a workaround.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

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

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