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Terminated

ACCESS Estradiol Reagent Test System

FDA Recall Z-0872-03 · Posted 2003-05-29

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeCHP
Date Initiated2003-05-08
Date Terminated2003-10-14
Product Quantity1593 kits

Reason for Recall

Short volume, resulting possibility of falsely elevated results.

Firm Action

Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc. · 1997-10-31

Official Source

View FDA Recall →

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

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