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U.S. Department of Health and Human Services

Class 2 Device Recall Access Free T4 Assay

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  Class 2 Device Recall Access Free T4 Assay see related information
Date Initiated by Firm March 24, 2010
Date Posted October 01, 2010
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-2658-2010
Recall Event ID 55196
510(K)Number K982250  
Product Classification Radioimmunoassay, Free Thyroxine - Product Code CEC
Product Access Immunoassay Systems Free T4, Part Number: 33880
Code Information Lot Number 916293
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact
714-993-5321
Manufacturer Reason
for Recall		 The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.
FDA Determined
Cause 2		 Other
Action A Product Corrective Action (PCA) letter was sent on March 24, 2010 to the affected customers. The letter provides the customers with an explanation of the problem identified and instructs them to discard the FT4 kit, Lot 916293 in their stock if the FT4 packs within the kit packaging are labeled as Vitamin B12 Lot 916277. The PCA requested customers: (1) Inspect all Access Vitamin B12 reagent packs that have been removed from their kit boxes, including reagent packs currently loaded on your system and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (2) Inspect your Access Free T4 reagent kit inventory for any reagent packs labeled as Access Vitamin B12, lot 916277 and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (3) Review your historical quality control to ensure that assay performance for Access Vitamin B12 lot 916277 has been within your laboratory specifications. In addition customers were instructed to share this information with their laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that you have received this important notification. If customers need assistance or have any questions regarding the notification, they were instructed to contact Customer Technical Support Center at 1-800-854-3633 in the United States and Canada.
Quantity in Commerce 10826
Distribution Nationwide In the US & 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 = CEC and Original Applicant = BECKMAN INSTRUMENTS, INC.
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