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U.S. Department of Health and Human Services

Class 3 Device Recall Genzyme

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 Class 3 Device Recall Genzymesee related information
Date Initiated by FirmApril 14, 2008
Date PostedAugust 22, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall NumberZ-2148-2008
Recall Event ID 48184
510(K)NumberK897150 
Product Classification Lipase - Product Code CHI
ProductEqual Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.
Code Information Reagent lot Number 491686, Lot #: 7EPM30 exp 01/15/09
Recalling Firm/
Manufacturer		 Genzyme Corporation
500 Kendall Street & 1 Kendall Square
Cambridge MA 02139
For Additional Information Contact
617-252-7500
Manufacturer Reason
for Recall		Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionGenzyme notified accounts by Fed'X on 4/14/08 via an Imprtant Field Correction letter, requesting users to discard kits and follow the "User Update" instructions previously provided to minimize calibration error. Customers are to complere and sign the Confirmation of Notification form and fax it back to the firm regardless if they have any affected product or not. Also, requires that the customer confirms that the REagent OD limits for First and Last H are set at 0.15 for Lipase on the Olympus AU400/400e, AU600, AU640/640e and AU2700/AU5400 Systems.
Quantity in Commerce3,443
DistributionNationwide Distribution
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 = CHI
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