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Terminated

Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.

FDA Recall Z-0165-2009 · Posted 2008-10-22

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJE
Date Initiated2008-06-24
Date Terminated2009-10-22

Reason for Recall

A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.

Firm Action

The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.

Root Cause

Other

Distribution Pattern

Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961481ELECSYS 2010 ANALYZERBoehringer Mannheim Corp. · 1996-06-14

Official Source

View FDA Recall →

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

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