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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJanuary 26, 2006
Date PostedMarch 23, 2006
Recall Status1 Terminated 3 on April 18, 2006
Recall NumberZ-0676-06
Recall Event ID 34687
510(K)NumberK930104 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
ProductGemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
Code Information Catalog Number: S1-32: Lot:  A31, Exp. 2/2006 (Kit lot #F1458); A41, Exp. 1/2007 (Kit lot # F1757, F1757A, F1757B, and F1757C).
FEI Number 1000122044
Recalling Firm/
Manufacturer		 Alfa Wassermann, Inc
4 Henderson Dr
West Caldwell NJ 07006-6608
For Additional Information ContactMr. Michael Malis
973-852-0158
Manufacturer Reason
for Recall		Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.
FDA Determined
Cause 2		Other
ActionField correction letters were sent to the firm's customers via FAX on 1/14/2006-1/17/2006 and via UPS on 1/17/2006-1/19/2006. An updated letter was sent out via FAX on 1/27,30,31/2006 and via UPS on 1/30/2006 and 2/1/2006.
Quantity in Commerce22,987 kits
DistributionThe kits were sent nationwide. The product was shipped to Alfa Wasserman's sister firm in Wergen, Netherlands. There are several US Navy accounts.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIX
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