Recall Z-2071-2011 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Synchron LX 20 PRO The SYNCHRON LX20 PRO is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent). Additionally, Synchron LX PRO System
| Date | Apr 26, 2011 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified. |
| Root cause | Environmental control |
| Action | The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete a |
| Quantity | 1410 total units (503 in US) |
| Distribution | Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Ku |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc., Mar 10, 1997 |