Recall Z-1945-2011 ยท CEC Radioimmunoassay, Free Thyroxine
Beckman Coulter Inc.
Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems
| Date | Apr 11, 2011 (initiated Nov 11, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met. The affected T4 calibrator lot can produce quality control and patient results that are erroneously low (by greater than 2 standard deviations). An erroneously low patient result may lead to misdiagnosis and/or delayed treatment. |
| Root cause | Other |
| Action | The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter dated November 29, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: ACTION/RESOLUTION: " Discontinue use of Access Free T4 calibrator lot 014769. " Review historical quality control performance and determine whether any reported patient results were obtained while using a faulty calibration. If results were affected, you will see a shift downward in control recovery that produces out-of-range low QC results. " If pati |
| Quantity | 459 units |
| Distribution | Worldwide distribution: USA and countries including: Argentina, Belgium, Bosnia and Herzegovina, Canada, China, Colombia, Czech Republic, French Polynesia, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Oman, Panama, Philippines, Russian Federation, South Africa, Switzerland, T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc., Jul 14, 1998 |