Z-1227-2017 Class II Terminated
FDA device recall Z-1227-2017 was initiated by Siemens Healthcare Diagnostics, Inc. on January 11, 2017 and is designated Class II. Reason for recall: The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stabili… The recall status is terminated (terminated June 12, 2018). Affected quantity: US: 62 kits; Foreign: 290 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2017
- Initiation Date
- January 11, 2017
- Termination Date
- June 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 62 kits; Foreign: 290 kits
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.