Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufacture
FDA device recall Z-1013-2010 · posted 2010-03-05 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.
- Action taken
- 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
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 613 units
- Distribution
- 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, P
- Date initiated
- 2009-06-15
- Date posted
- 2010-03-05
- Date terminated
- 2011-02-02
- Location
- Hercules, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU (K070452) | Bio-Rad Laboratories, Inc. | 2007-05-07 |