Recall Z-1034-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
| Date | Apr 1, 2013 (initiated Feb 12, 2013) |
| Status | Terminated |
| Reason | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results. |
| Root cause | Device Design |
| Action | Beckman Coulter sent an "Urgent Product Correction" letter dated February 12, 2013 via mail and email to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to place your Access system in the Ready or Not Ready mode. Lift the cover (as you do to access the probes) and look at the left side of the incubator unit under the peripump by the aspirate probe, if you see a silver pulley, immediately discontinue use and contact Technical Support also check for QC failures and system check failures; If you see a white pulley, this is the corr |
| Quantity | 83 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc., Oct 4, 2002 |