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Terminated

DL 2000 Data Manager

FDA Recall Z-1372-05 · Posted 2005-08-16

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2005-06-20
Date Terminated2011-10-06
Product Quantity287

Reason for Recall

Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.

Firm Action

Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.

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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