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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.

FDA Recall Z-1473-2014 · Posted 2014-04-18

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeLIB
Date Initiated2014-03-17
Date Terminated2014-12-11
Product Quantity72/50-test boxes

Reason for Recall

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

Firm Action

The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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