Recall Z-0238-2016
Focus Diagnostics Inc · initiated October 2, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Codes / lots: 26341, 27011
Reason for recall
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
FDA-determined cause: Device Design
Action taken
A recall letter dated 10/2/15 was sent to distributors who distributed the Anaplasma phagocytophilum IFA IgM (IF1450M) kit lots 26431 and 27011. The letter informs the customers that Focus Diagnostics received customer complaints of IF1450M with low reactivity, which may result in higher invalid rate. The letter also provides the customers with Focus Diagnostics' recommendations and actions to be taken by the distributors. Customers with questions or require additional information are instructed to contact Focus Diagnostics' Technical Services department at (562) 240-6550 from 7am to 5pm (PST) or send an email to DxTS@focusdx.com.
Details
- Recall number
- Z-0238-2016
- Initiated
- October 2, 2015
- Posted by FDA
- November 6, 2015
- Terminated
- January 29, 2016
- Product code
- OTT – Research Use Only/Microbiology
- Quantity
- 38 kits
- Distribution
- Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
- Recalling firm
- Focus Diagnostics Inc, Cypress, CA