Luminex Corporation: Medical Device Recall in 2021 - (Recall #: Z-2010-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

Product Classification:

Class II

Date Initiated: October 30, 2020

Date Posted: July 14, 2021

Recall Number: Z-2010-2021

Event ID: 88137

Reason for Recall:

Potential for a false-negative result.

Status: Ongoing

Product Quantity: 1,261

Code Information:

041520022A, 061920022A, and 081120022A

Distribution Pattern:

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated