COULTER LH 750 Hematology Analyzer.

FDA device recall Z-0536-05 · posted 2005-02-10 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation's database are not affected.

Action taken

Letter 12/20/04 A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation''s database are not affected. If the LH750 instrument displays a pop-up winder titled Database Error (XXXXXX) and text similar to (Microsoft) (ODBC SQL...) As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Do not acknowledge the error. Instead, restart the entire system by completely powering it OFF and then ON. Or, if the LH750 Workstation experiences a change in performance, such as screen display freezes, slow response time, or requires frequent resets to continue processing. As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Verify the accuracy of all patient reports for the samples until service confirms the performance of system.

Root cause

Other

Status

Terminated

Product code

GKZ

Quantity affected

1,257

Distribution

US and Canada

Date initiated

2004-12-16

Date posted

2005-02-10

Date terminated

2012-04-26

Location

Brea, CA