CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report

Anaplasma Phagocytophilum IFA IgM Test Kit recalled by Focus Diagnostics

Focus Diagnostics is recalling Anaplasma Phagocytophilum IFA IgM Test Kit. The recall was initiated on 2 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes26341, 27011

Quantity recalled38 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0238-2016
FDA event ID: 72395
Recalling firm: Focus Diagnostics, Cypress, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 Oct 2015
FDA classified: 6 Nov 2015
Reported: 18 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

2 Oct 2015	Recall initiated by company
6 Nov 2015	Classified by FDA	+35 days
18 Nov 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

Product as listed by the FDA

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

Where it was distributed

Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia

Questions about this recall

Why was it recalled?

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

Which lots are affected?

26341, 27011

Where was it sold?

Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Focus Diagnostics

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