Remel Inc: Medical Device Recall in 2013 - (Recall #: Z-0806-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.

Product Classification:

Class II

Date Initiated: August 20, 2012

Date Posted: February 20, 2013

Recall Number: Z-0806-2013

Event ID: 63558

Reason for Recall:

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

Status: Terminated

Product Quantity: 493 of lot 082505; 529 of lot 131988; and 448 of lot 131994

Code Information:

Lots: 082505; 131988; 131994

Distribution Pattern:

Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated