DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Reason: Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fdaU.S. Food and Drug Administration. It handles food, drink, cosmetic and medication recalls. Learn more →.hhs.gov in any discussions on change/elevation of recallsThe maker or a government agency pulled this product. Check the model or lot number and stop using it until it's fixed or refunded. to Class IThe FDA's most serious recall level: a reasonable chance the product could cause serious health problems or death. classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.
Class II · Ongoing · Worldwide - US Nationwide distribution.