Phadia Ab recalls EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measu…

Recall date

December 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0697-2016

FDA classification

Class II

Brand / firm

Phadia Ab

Sold / distributed

US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.