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U.S. Department of Health and Human Services

Class 2 Device Recall IGFBP3 IRMA Kit

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 Class 2 Recall
IGFBP3 IRMA Kit
see related information
Date Posted September 28, 2010
Recall Status1 Terminated on August 13, 2012
Recall Number Z-2607-2010
Recall Event ID 56485
Premarket Notification
510(K) Number
K950228 
Product Classification Radioimmunoassay, Human Growth Hormone - Product Code CFL
Product IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.
Code Information Lot Numbers: 991017, 991225, 991384, 991694, 991938, 992171, 992372, 992703, 100115A, 100205A, 100205B, 100226A, 100319A, 100409A, 100409B, 100430A and 100521A
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea, California 92821-6208
For Additional Information Contact Clair K. ODonovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1. The investigation confirmed that above mentioned lots of IGFBP-3 kit provide results elevated by 84% on average. Erroneously elevated IGF
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action The recall communication was initiated with a Product Corrective Action (PCA) letter that was sent on August 09, 2010 to all customers who received the IGFBP-3 IRMA kits, lot numbers referenced. The letter will provide the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: (1) Discontinue using all lots identified above and discard in accordance with local regulations. (2) To continue testing for IGFBP-3 levels, find an alternate method. (3) Immediately notify all parties of interest (e.g., laboratory staff, clinicians) of the possibility of erroneously elevated IGFBP-3 results for patient samples tested with these lots, and advise all parties that clinical decision making and patient safety may be impacted. (4) Review patient IGFBP-3 results for the lots listed above, and interpret them in the light of additional tests (e.g., IGF-1) and the patient's clinical status and history. Customers were also asked to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For any questions regarding this notification, customers were to contact the DSL Technical Support Center at 1-800-231-7970 option 4 in the United States, or contact your local Beckman Coulter Representative.
Quantity in Commerce 63
Distribution Nationwide in US and Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CFL and Original Applicant = DIAGNOSTIC SYSTEMS LABORATORIES, INC.
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