Recall Z-0238-2016— Focus Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Focus Diagnostics Inc, initiated 2015-10-02, terminated 2016-01-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.. Reason: Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results..
- Recalling firm
- Focus Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-02
- Terminated
- 2016-01-29
- Firm location
- Cypress, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.