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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465

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  Class 2 Device Recall SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465 see related information
Date Initiated by Firm October 25, 2004
Date Posted November 30, 2004
Recall Status1 Terminated 3 on June 17, 2005
Recall Number Z-0262-5
Recall Event ID 30362
510(K)Number k970905  
Product Classification Lipase-Esterase, Enzymatic, Photometric, Lipase - Product Code CHI
Product SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
Code Information Part number: 465101  Lot Numbers - Date of Mfg - Expiration Date M310237 - 10/29/2003 - 10/31/2004 M401010 - 01/15/2004 - 01/31/2005  M403026 - 03/05/2004 - 03/31/2005 M406041 - 06/10/2004 - 06/30/2005
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Kathleen M. Jaker
714-966-3666
Manufacturer Reason
for Recall		 Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina substantial positive bias affecting Lipase (LIPA) results.
FDA Determined
Cause 2		 Other
Action The week of 10/25/2004, a product corrective action (PCA) letter was mailed vis U.S. mail to all customers shipped LIPA reagent for the 24 months preceding the discovery of the issue. Customers instructed to repeat any sample that produces a lipase value of > 170 U/L that cannot be confirmed by patient history.
Quantity in Commerce 6,698
Distribution US and Canada
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 = CHI and Original Applicant = BECKMAN INSTRUMENTS, INC.
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