EliA SmDP Well, Article Number 14-5624-01 — recall Z-0697-2016
U.S. FDA — Device Enforcement · Sweden · 2015-12-28 · Class II
As described by U.S. FDA — Device Enforcement: EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with o
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
Reported risk: 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.
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