Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit — Class II medical device recall Z-0238-2016
Terminated recall by Focus Diagnostics Inc, reported 2015-11-18. Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in
| Recall number | Z-0238-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focus Diagnostics Inc, Cypress, CA, United States |
| Recall initiated | 2015-10-02 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-01-29 |
| Countries outside the US | CO, CZ, DE, DK, ES, IT |
| Quantity | 38 kits |
| Model numbers | IF1450M |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0238-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.