Z-0238-2016 Class II Terminated
FDA device recall Z-0238-2016 was initiated by Focus Diagnostics Inc on October 2, 2015 and is designated Class II. Reason for recall: Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results. The recall status is terminated (terminated January 29, 2016). Affected quantity: 38 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2015
- Initiation Date
- October 2, 2015
- Termination Date
- January 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 kits
Product Description
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Reason for Recall
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
Distribution Pattern
Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
Code Information
26341, 27011