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Terminated

Array Systems Calibrator 5 Part No. 465250

FDA Recall Z-1152-04 · Posted 2004-07-23

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGTQ
Date Initiated2003-12-17
Date Terminated2004-08-30
Product Quantity1000

Reason for Recall

The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K926236BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc. · 1993-06-15

Official Source

View FDA Recall →

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

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