Remel Inc: Medical Device Recall in 2014 - (Recall #: Z-1473-2014)

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 Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.

Product Classification:

Class II

Date Initiated: March 17, 2014

Date Posted: April 30, 2014

Recall Number: Z-1473-2014

Event ID: 67777

Reason for Recall:

A reagent contained within the product may return false negative results.

Status: Terminated

Product Quantity: 72/50-test boxes

Code Information:

DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014

Distribution Pattern:

Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated