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U.S. Department of Health and Human Services

Class 3 Device Recall Waco Lipoprotein (a) Calibrator

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 Class 3 Device Recall Waco Lipoprotein (a) Calibratorsee related information
Date Initiated by FirmJuly 06, 2006
Date PostedAugust 25, 2006
Recall Status1 Terminated 3 on September 14, 2006
Recall NumberZ-1409-06
Recall Event ID 35885
510(K)NumberK981446 
Product Classification Lipoprotein (a) Calibrator - Product Code MMY
ProductLp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan
Code Information Lots Numbers-EK560 EXP 7/31/06 and EH213 EXP 9/30/06
FEI Number 3005625991
Recalling Firm/
Manufacturer		 Wako Chemicals, USA Inc
1600 Bellwood Road
Richmond VA 23237-1326
For Additional Information ContactLori Creasy
804-714-1924
Manufacturer Reason
for Recall		Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.
FDA Determined
Cause 2		Process control
ActionThe recalling firm notified consignees by phone and e-mail with an attached letter dated 07/06/06. The notification, flagged as ''Important Device Recall'' advised consignees to stop using the recalled product and that Lp(a) results showed a decrease in value of approximately 10% when the identified lots are used. Consignees were requested to return the enclosed response form for replacement product.
Quantity in Commerce136 kits
DistributionThe product was sold to one distributor and direct medical accounts Nationwide.
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 = MMY
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