RecallRadar

FDA Device recall Z-1474-2014

Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box

On 2014-04-30 the FDA classified a Class II recall of Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box by Remel, citing A reagent contained within the product may return false negative results.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1474-2014
ClassificationClass II
Statusterminated
Initiated2014-03-17
Published2014-04-30
Last updated2026-09-13 11:53 UTC
CompanyRemel
DistributionCA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, VT

Product

Oxoid Legionella Pneumo Groups 2-14, DR0802M, 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

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

Identifiers

code_infoDR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1474-2014%22

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