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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter Access Free T3 Calibrator

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  Class 2 Device Recall Beckman Coulter Access Free T3 Calibrator see related information
Date Initiated by Firm December 17, 2009
Date Posted May 10, 2011
Recall Status1 Terminated 3 on March 29, 2012
Recall Number Z-2178-2011
Recall Event ID 55952
510(K)Number K042651  
Product Classification in vitro diagnostic - Product Code JIT
Product Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.
Code Information Lot #'s: 989902, 989903, 989904, 989905, 989906 & 989907
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
Manufacturer Reason
for Recall		 Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Beckman Coulter sent a letter dated December 29, 2009, providing the customers with an explanation of the reason for recall and asked them to take the following actions: - Discontinue use of the lots of reagent listed above. - Review your historical quality control to ensure that the assay performance of these lots has been within your laboratory specifications. NOTE: Out-of-range high quality control results may indicate invalid test results. Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed response form within 10 days so that Beckman can be assured that they received this important notification. Assistance or questions regarding this notification, were directed to Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.
Quantity in Commerce 2,320 kits
Distribution Distribution Nationwide 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 = JIT and Original Applicant = BECKMAN COULTER, INC.
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