Recall Z-2354-2016
Alere San Diego, Inc. · initiated July 11, 2016
Class I – dangerous or defective products that could cause serious health problems or death
Product
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio 2 Monitor and INRatio 2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.
Codes / lots: All Lots All Serial Numbers
Reason for recall
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
FDA-determined cause: Other
Action taken
Alere issued a press release on July 11, 2016. An Urgent Medical Device Letter dated July 26, 2016 was sent to affected customers on July 29, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to consult with their healthcare provider as soon as possible to transition to an alternate method of PT/INR testing and to contact the firm regarding return or disposal of unused product and obtaining device replacement from a different manufacturer. For questions contact the Alere INRatid1 Recall Hotline at 1-866-723-2535.
Details
- Recall number
- Z-2354-2016
- Initiated
- July 11, 2016
- Posted by FDA
- August 19, 2016
- Terminated
- July 20, 2017
- Product code
- GJS – Test, Time, Prothrombin
- Distribution
- Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand…
- Recalling firm
- Alere San Diego, Inc., San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2355-2016 Class I | INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | 07/11/2016Terminated |
| Z-2356-2016 Class I | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | 07/11/2016Terminated |
| Z-2357-2016 Class I | Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage:…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | 07/11/2016Terminated |
| Z-2358-2016 Class I | Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System… | 07/11/2016Terminated |
| Z-2359-2016 Class I | Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System… | 07/11/2016Terminated |
| Z-2360-2016 Class I | Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage:…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | 07/11/2016Terminated |
| Z-2361-2016 Class I | Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | 07/11/2016Terminated |
| Z-2362-2016 Class I | Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Test Strips. This… | 07/11/2016Terminated |