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U.S. Department of Health and Human Services

Class 2 Device Recall DSL108000 Active IPTH ELISA

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  Class 2 Device Recall DSL108000 Active IPTH ELISA see related information
Date Initiated by Firm March 04, 2010
Date Posted October 20, 2010
Recall Status1 Terminated 3 on April 27, 2012
Recall Number Z-0107-2011
Recall Event ID 55195
510(K)Number K952199  
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
Product Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000
The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
Code Information Lot Numbers: 891198, 990980, 991448
Recalling Firm/
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K. ODonovan, Ph.D.
Manufacturer Reason
for Recall
The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay may not be achieved for lot numbers: 891198, 990980 and 991448. The kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. Therefore the affected I-PTH ELISA kit lots may produce falsely elevated patient r
FDA Determined
Cause 2
Action Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448; (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your laboratory uses only the control materials provided with the I-PTH ELISA kit; (3) Abnormally elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests; (4) I-PTH ELISA kit lot numbers 891198, 990980 and 991448 will no longer be shipped. Alternate lots will be provided for current and future replenishment orders or requests. in addition customers were instructed to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For questions regarding this recall contact (800) 231-7970.
Quantity in Commerce 70 kits
Distribution Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
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 = CEW and Original Applicant = DIAGNOSTIC SYSTEMS LABORATORIES, INC.