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U.S. Department of Health and Human Services

Class 2 Device Recall Sm ELISA Test System

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  Class 2 Device Recall Sm ELISA Test System see related information
Date Initiated by Firm August 19, 2008
Date Posted March 31, 2009
Recall Status1 Terminated 3 on April 30, 2009
Recall Number Z-1089-2009
Recall Event ID 49438
510(K)Number K941409  
Product Classification Antinuclear Antibody Immunological Test System - Product Code LJM
Product Sm ELISA Test System
Product number 2Z2831G and Product number 43270CE
Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70.
Manufactured by Zeus Scientific, Raritan, NJ 08869-0038.
Also manufactured for Wampole Laboratories, Princeton, NJ 08540

Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.
Code Information Lot number 08041819, Exp. 11/2009;, Lot number 08041811, Exp. 11/2009 (Inverness Medical - Wampole)
Recalling Firm/
Manufacturer		 Zeus Scientific Inc
200 Evans Way
Somerville NJ 08876-3767
For Additional Information Contact Susan Steiner, Ph.D.
908-526-3744
Manufacturer Reason
for Recall		 The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.
FDA Determined
Cause 2		 Employee error
Action Urgent Recall Notice letters were sent out by Federal Express night mail on August 19, 2008 to all direct account. Wampole (Inverness) will notify their customers in a separate letter. Recall letters explained the reason for the recall and that the product does meet the company's criteria when it is used qualitatively to interpret index values or OD rations as outlined in the kit package insert. Customers are advised in the letter that the Calibrator Value of 102 is incorrect and that it should be 266. Instructions to correctly express the specimen results using specimen and calibrator OD values semi-qualitatively as Unit Values and the Calibrator Value (CV) or 266 are included. Letters also state that results for all patients using the incorrect CV of 102 should be recalculated using the correct CV of 266. All letters included a fax back form indicating that they have received the recall notification, have notified customers to correct the CV value for the Semi-Quantitative Conversion and have notified customers that have received the kit to correct the Semi-Quantitative Conversion of Optical Density to AAU/mL for the affected lot number of the Sm ELISA Test System.
Quantity in Commerce 33 of lot 08041819, 27 of lot 08041811.
Distribution Nationwide Distribution
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 = LJM and Original Applicant = ZEUS SCIENTIFIC, INC.
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