EliA SmDP Well · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2015-12-28	Z-0697-2016	Class II	Terminated	All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.Distribution: US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.	76	clearance family

Regulatory clearances

510(k)K132631Substantially equivalent (SESE) · 2014-08-29clearance family

Predicate lineage

K132631

Cited as predicate by: K183007, K202067

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility
2013-11-21	NAI	No action indicated	Phadia GmbH
2011-08-18	NAI	No action indicated	Phadia Ab
2011-08-18	NAI	No action indicated	Phadia Ab

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