Device Recall Variant II Hemoglobin Testing System with CDM v 4.0 의 리콜

Recall

50531

Class 2

Z-1395-2009

2008-12-09

2009-05-19

Terminated

United States

2010-11-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75711

The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.

Recall initiated on December 10, 2008. Notification conducted by phone call and fax for domestic consignees. Each subsidiary will receive the subsidiary Urgent: Medical Device Correction notice, customer medical device correction response form and number of customers distributed to by e-mail. Each subsidiary must contact customers and provide the customer notice and response form as needed. The notice stated that Bio-Rad Laboratories would release a follow up communication providing a permanent solution upon completion of an investigation. In the interim, it was recommended that customers carefully review the Summary Report for duplicate barcode IDs or or tube position numbers within the same rack. If there are any questions or assistance needed, the local regional Bio-Rad office should be contacted.