Recall Z-2047-2011 ยท CFT Radioimmunoassay, Prolactin (Lactogen)
Beckman Coulter Inc.
Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
| Date | Apr 20, 2011 (initiated Aug 3, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio |
| Root cause | Equipment maintenance |
| Action | The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" Letter dated August 03, 2009 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: Action/Resolution: Discontinue use and discard remaining product with lot number 890291 of Active Prolactin reagents. Contact Beckman Coulter at 1-800-231-7970 for replacement product. Newer lots (lot number 991210 or higher) of the product have been realibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation |
| Quantity | 30 Kits |
| Distribution | Nationwide distribution: USA including states of: FL, GA and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 Diagnostic Systems Laboratories, Inc., Apr 26, 1996 |