Recall Z-2761-2011 ยท CGR Radioimmunoassay, Cortisol
Beckman Coulter Inc.
Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.
| Date | Jul 8, 2011 (initiated Jul 20, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control ELISA reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. Beckman Coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica |
| Root cause | Other |
| Action | Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970. Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number |
| Quantity | 1369 Kits |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884689 | DSL 7800 ACTIVE CORTISOL Diagnostic Systems Laboratories, Inc., Feb 23, 1989 |