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Terminated

Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

FDA Recall Z-1148-03 · Posted 2003-08-21

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeKLS
Date Initiated2003-06-18
Date Terminated2004-04-20
Product Quantity1615

Reason for Recall

Defective software media distributed with upgrade software may cause installation failure and systems lock.

Firm Action

Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media.

Root Cause

Other

Distribution Pattern

United States only, nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922823ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTSBio-Rad Laboratories, Inc. · 1992-08-05

Official Source

View FDA Recall →

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

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