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Terminated

Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.

FDA Recall Z-0619-03 · Posted 2003-03-06

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-01-27
Date Terminated2003-10-08
Product Quantity2418

Reason for Recall

Spring failure, design defect in component.

Firm Action

A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment)

Root Cause

Other

Distribution Pattern

Product has been distributed in US from 8/92 to present. All these units are affected.

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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