Recall Z-2882-2011 ยท JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Beckman Coulter Inc.
DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.
| Date | Jul 26, 2011 (initiated Sep 9, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient samples. |
| Root cause | Process control |
| Action | Beckman Coulter sent an "URGENT: PRODUCT CORRECTION ACTION" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol, 17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was |
| Quantity | 3,542 units (1181 in US) |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921534 | DSL DHEA (DSL 8900) Diagnostic Systems Laboratories, Inc., May 26, 1992 |