PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 30, 2014 Initiated: March 17, 2014 #Z-1473-2014

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.

Reason for Recall

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

Details

Recalling Firm
Remel Inc
Units Affected
72/50-test boxes
Distribution
Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
Location
Lenexa, KS

Frequently Asked Questions

What product was recalled?
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.. Recalled by Remel Inc. Units affected: 72/50-test boxes.
Why was this product recalled?
A reagent contained within the product may return false negative results.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 30, 2014. Severity: Moderate. Recall number: Z-1473-2014.