EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vit...
FDA Recall #Z-0697-2016 — Class II — December 28, 2015
Product Description
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.
Reason for Recall
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.
Recalling Firm
Phadia Ab — Uppsala, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
76
Distribution
US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
Code Information
Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated