Recall Z-0584-2011 ยท CEW Radioimmunoassay, Parathyroid Hormone
Beckman Coulter Inc.
Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 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.
| Date | Dec 9, 2010 (initiated Apr 22, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected by the recall. The affected I-PTH ELISA and the I-PTH IRMA kit lots may produce falsely elevated patient results. Internal stability testing showed an average 16% elevation for I-PTH ELISA lot 99 |
| Root cause | Pending |
| Action | Beckman Coulter sent an Urgent Product Corrective Action Letter to their consignees dated June 18, 2010. The letter identified the product, the problem, and the action to be taken. Consignees were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372. (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if their laboratory uses only the Control materials provided with the I-PTH EL |
| Quantity | 3 kits |
| Distribution | Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952199 | ACTIVE INTACT PTH ELISA Diagnostic Systems Laboratories, Inc., Jul 17, 1995 |