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Recall Observatory FDA recall evidence

Device 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.

Z-1474-2014

March 17, 2014

Class II

Product summary

Firm
Remel Inc
Event
Event 67777
Status
Terminated
Classification
Class II
Quantity
2/50-test boxes
Official record key
device-enforcement:Z-1474-2014

Official wording

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

Code information: DR0802M box lot number 1265362, Exp. 30Jun2014; 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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