Atlas FDA

DL 2000 Data Manager

FDA device recall Z-1372-05 · posted 2005-08-16 · Terminated

Recall details

Recalling firm
Beckman Coulter Inc
Reason for recall
Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.
Action taken
Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.
Root cause
Other
Status
Terminated
Product code
JQP
Quantity affected
287
Distribution
Nationwide.
Date initiated
2005-06-20
Date posted
2005-08-16
Date terminated
2011-10-06
Location
Brea, CA

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