Z-0238-2016Class II

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic

Name: Z-0238-2016 Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic
Creator: Focus Diagnostics Inc
Published: 2015-10-02
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2015-10-02 / Terminated / root cause: design

FDA source

Focus Diagnostics Inc began a recall of Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic on 2015-10-02. FDA classified it as Class II and gives the reason as "Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0238-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-02
Posted: 2015-11-06
Terminated: 2016-01-29
Recalling firm: DiaSorin Molecular LLC
Product: Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Product code: OTT Research Use Only/Microbiology
Reason for recall: Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected].
Quantity in commerce: 38 kits
Distribution: Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
Product codes and lots: 26341, 27011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0238-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0238-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code OTT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)