Device Recall Beckman Coulter, COULTER LH 750 의 리콜

Recall

30732

Class 2

Z-0536-05

2004-12-16

2005-02-10

Terminated

United States

2012-04-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36473

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.

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.