FDAClass IIJanuary 1, 2014

Captia Syphilis-G Test Kit Product Usage: This is an recall

Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum…

Why was Captia Syphilis-G Test Kit Product Usage: This is an recalled?

Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative 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?

Product Code: 800-960, Lot number: 082, Model: 10 - plate kit

Product
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum…
Recalling firm
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Quantity
38 kits
Distribution
USA Nationwide Distribution in the state of WA
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls