Focus Diagnostics Anaplasma Phagocytophilum IFA IgM recall
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Why was Focus Diagnostics Anaplasma Phagocytophilum IFA IgM recalled?
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
26341, 27011
- Product
- Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
- Recalling firm
- Focus Diagnostics Inc
- Quantity
- 38 kits
- Distribution
- Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
- Recall date
- November 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)