Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
FDA Recall Z-1013-2010 · Posted 2010-03-05
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Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLCP
Date Initiated2009-06-15
Date Terminated2011-02-02
Product Quantity613 units
Reason for Recall
Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.
Firm Action
Recall initiated June 15, 2009, with notification initially conducted by phone with Fax Notification follow up domestically. Each subsidiary will be given an urgent notice, subsidiary response form, customer notification, customer acknowledgement form. Each subsidiary is to contact customers and translate notification and response form as needed. Contact the recalling firm for additional information.
Root Cause
Other
Distribution Pattern
Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom
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.
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