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U.S. Department of Health and Human Services

Class 2 Device Recall ACCESS Ostase

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  Class 2 Device Recall ACCESS Ostase see related information
Date Initiated by Firm June 22, 2011
Date Posted March 09, 2012
Recall Status1 Terminated 3 on March 09, 2012
Recall Number Z-1195-2012
Recall Event ID 61145
510(K)Number K994278  
Product Classification Electrophoretic separation, alkaline phosphatase isoenzymes - Product Code CIN
Product ACCESS Ostase

Part Number: 37300

Used for the quantitative measurement of bone alkaline phosphatase (BAP).
Code Information Lot Number: 021281
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		 The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.
FDA Determined
Cause 2		 Process design
Action A recall communication was initiated on 6/15/2011 with Beckman forwarding an "Urgent Product Correction" (PCA) letter to all their customers who purchased the Access Immunoassay Systems Ostase Reagent Kits. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the Access Ostase reagent lot identified on the PCA letter and discard all remaining inventory. As stated in the Instructions for Use for Access Ostase, results should be interpreted in light of the total clinical presentation of the patient. All results generated with reagent lot number 021281 where patient results are higher than expected should be evaluated. The affected lot has been removed from Beckman's inventory, and alternate lots will be provided for all current and future replenishment orders or requests. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions can contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call(800) 854-3633 in the US and Canada.
Quantity in Commerce 318 units total (44 units in US)
Distribution Worldwide Distribution -- US, including states of FL, IN, VA, CA, and KY and countries of China, Japan, and Panama.
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 = CIN and Original Applicant = BECKMAN COULTER, INC.
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