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Terminated

Access 2 immunoassay side of LXi 725

FDA Recall Z-0693-03 · Posted 2003-03-29

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Date Initiated2003-01-30
Date Terminated2004-06-01
Product Quantity10

Reason for Recall

False results from secondary pour off tubes

Firm Action

Customers with the Access 2 instrument were informed of the recall issue by letter dated 1/30/2003. Those with the LXi 725 were informed by a letter dated 2/5/2003. The letters caution not to use certian Pour off tubes.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023049SYNCHRON LX I 725 CLINICAL SYSTEMBeckman Coulter, Inc. · 2002-10-04

Official Source

View FDA Recall →

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

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