SYNCHRON Clinical Systems Enzyme Validator Kit
FDA Recall Z-1378-04 · Posted 2004-08-17
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJIX
Date Initiated2004-07-29
Date Terminated2005-02-03
Product Quantity771
Reason for Recall
incorrect Calibration Acceptance Limits.
Firm Action
Recall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette.
Root Cause
Other
Distribution Pattern
Nationwide & Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.