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U.S. Department of Health and Human Services

Class 2 Device Recall EliA

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  Class 2 Device Recall EliA see related information
Date Initiated by Firm December 28, 2015
Date Posted January 28, 2016
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = PHADIA US INC.
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