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U.S. Department of Health and Human Services

Class 3 Device Recall Inhibin A ELISA Kit

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 Class 3 Device Recall Inhibin A ELISA Kitsee related information
Date Initiated by FirmDecember 21, 2010
Date PostedApril 08, 2011
Recall Status1 Terminated 3 on August 31, 2012
Recall NumberZ-1925-2011
Recall Event ID 57866
Product Classification Enzyme immunoassay, inhibin-a - Product Code NDR
ProductInhibin A ELISA kit, Part Number: DSL-10-28100-4 The Inhibin A ELISA kit is intended for the quantitative measurement of Dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
Code Information Lot #: 090779 (EXP: 02/04/2011), 091046 (EXP: 02/16/2011), 091053(EXP: 11/09/2011)
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information ContactClair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.
FDA Determined
Cause 2		Pending
ActionBeckman Coulter sent an Urgent Product Corrective Action letter dated December 21, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and discard all remaining inventory. In addition customers were requested to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form within 10 days so Beckman could be assured that customers received this important notification. For product replacement: 1. In the United States, please contact Customer Service at 1-800-526-3821, option 1. 2. In Canada, please contact Customer Service at 1-800-463-7828. 3. Outside of the United States and Canada, contact your local Beckman Coulter representative. Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. For those customers outside the United States and Canada, instructions were given to contact their local Beckman Coulter representative.
Quantity in Commerce740 total units for both products
DistributionWorldwide Distribution - USA including NY, IN, PA, NM, OH, TX, AZ, NC, TN, MI and CT and the countries Denmark, Germany, Spain, Turkey, United Arab Emirates, United Kingdom.
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.
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