Z-2482-2015 Class II Terminated
FDA device recall Z-2482-2015 was initiated by Bayer Healthcare, LLC on June 22, 2015 and is designated Class II. Reason for recall: If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood g… The recall status is terminated (terminated May 23, 2016). Affected quantity: 5 million bottles of control solution.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- June 22, 2015
- Termination Date
- May 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 million bottles of control solution
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, Lithuania, Philippines, Romania, Serbia, Slovakia, and Thailand.