Atlas FDA

Array Systems Calibrator 5 Part No. 465250

FDA device recall Z-1152-04 · posted 2004-07-23 · Terminated

Recall details

Recalling firm
Beckman Coulter Inc
Reason for recall
The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.
Root cause
Other
Status
Terminated
Product code
GTQ
Quantity affected
1000
Date initiated
2003-12-17
Date posted
2004-07-23
Date terminated
2004-08-30
Location
Brea, CA

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Related 510(k) clearances

RecordFirmDate
BECKMAN ANTI-STREPTOLYSIN O KIT (K926236)Beckman Instruments, Inc.1993-06-15