Remel Inc: Medical Device Recall in 2014 - (Recall #: Z-0466-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.

Product Classification:

Class II

Date Initiated: October 23, 2014

Date Posted: December 3, 2014

Recall Number: Z-0466-2015

Event ID: 69566

Reason for Recall:

A reagent within the test may return false negative results.

Status: Terminated

Product Quantity: 59/50 test boxes

Code Information:

DR0800M box lot 1316151, Exp. 30Sep2014

Distribution Pattern:

Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.

Voluntary or Mandated:

Voluntary: Firm initiated