Luminex Corporation: Medical Device Recall in 2021 - (Recall #: Z-2451-2021)

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 EP Amplification Reagent Kit Test

Product Classification:

Class II

Date Initiated: August 3, 2021

Date Posted: September 22, 2021

Recall Number: Z-2451-2021

Event ID: 88423

Reason for Recall:

There is potential for false positive results.

Status: Ongoing

Product Quantity: 4579 kits

Code Information:

Model: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023; Lots: 111620023A 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated