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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron Phenobarbital (PHE) Drug Calibrator 1

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 Class 2 Device Recall Synchron Phenobarbital (PHE) Drug Calibrator 1see related information
Date Initiated by FirmAugust 11, 2009
Date PostedMarch 06, 2012
Recall Status1 Terminated 3 on December 05, 2013
Recall NumberZ-1173-2012
Recall Event ID 60937
510(K)NumberK955644 
Product Classification Enzyme immunoassay, phenobarbital - Product Code DLZ
ProductSynchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.
Code Information M810440 and earlier
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBeckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 26, 2009 to all customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Customers were asked to complete and return a response form. Contact Beckman Coulter Customer Support Center (Hotline) at (800) 854-3633 for questions regarding this recall.
Quantity in Commerce78,585 units total (75,385 in the US)
DistributionWorldwide Distribution--USA (nationwide) and the country of Canada.
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 = DLZ
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