Phadia Prime software recall
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays.…
Why was Phadia Prime software recalled?
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
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?
Phadia Prime software 12-4101-00 Phadia 250 12-3900-01 Listed software: EliA dsDNA Well 14-5500-01 EliA U1RNP Well 14-5501-01 EliA Sm Well 14-5502-01 EliA Ro Well 14-5503-01 EliA La Well 14-5504-01 EliA CENP Well 14-5505-01 EliA Scl-70 Well 14-5506-01 EliA Jo-1 Well 14-5507-01 EliA Symphony Well 14-5508-01 EliA RNP70 Well 14-5511-01 EliA GBM Well 14-5514-01 EliA CCP Well 14-5515-01 EliA Celikey IgA Well 14-5517-01 EliA Celikey IgG Well 14-5518-01 EliA Gliadin IgA Well 14-5519-01 EliA Gliadin IgG Well 14-5520-01 EliA Cardiolipin IgA Well 14-5528-01 EliA Cardiolipin IgG Well 14-5529-01 EliA Cardiolipin IgM Well 14-5530-01 EliA B2-Glycoprotein I IgA Well 14-5531-01 EliA B2-Glycoprotein I IgG Well 14-5532-01 EliA B2-Glycoprotein I IgM Well 14-5533-01 EliA PR3S Well 14-5536-01 EliA MPOS Well 14-5537-01 EliA GliadinDP IgA Well 14-5538-01 EliA GliadinDP IgG Well 14-5539-01 EliA RF IgM Well 14-5600-01 EliA RF IgA Well 14-5601-01 EliA SmDP Well 14-5624-01 EliA Scl-70S Well 14-5637-01 EliA anti-TPO Well 14-5641-01 EliA anti-TG Well 14-5642-01 EliA M2 Well 14-5649-01
- Product
- Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays.…
- Recalling firm
- Phadia Ab
- Quantity
- 2307
- Distribution
- US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR
- Recall date
- April 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)