FDAClass IIFebruary 20, 2013

Remel Xpect Clostridium difficile Toxin A/B recall

Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro…

Why was Remel Xpect Clostridium difficile Toxin A/B recalled?

The firm is recalling the products due to a potential for false negative test 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?

Lot 141764

Product
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro…
Recalling firm
Remel Inc
Quantity
50 units
Distribution
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Recall date
February 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls