Class 2 Device Recall EliA

• Date Initiated by Firm: December 28, 2015
• Date Posted: January 28, 2016
• Recall Status: Terminated on August 16, 2016
• Recall Number: Z-0697-2016
• Recall Event ID: 72969
• 510(K)Number: K132631
• Product Classification: Anti-sm antibody, antigen and control - Product Code LKP
• Product: 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.
• Code Information: Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
• FEI Number: 3002807876
• Recalling Firm/ Manufacturer: Phadia Ab; Rapsgatan 7; Rapsgatan Plant; Uppsala Sweden
• For Additional Information Contact: Martin R. Mann; 800-346-4364 Ext. 2
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 12/28/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions call 1-800-3464364, option #2.
• Quantity in Commerce: 76
• Distribution: US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LKP