Recall Z-0452-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part Number 474171 Product Usage: The UniCel DxC and LX Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urin
| Date | Jan 11, 2012 (initiated Sep 2, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that the Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample syringe barrel and plunger could lead to leaking and may affect results. |
| Root cause | Component design/selection |
| Action | Beckman Coulter sent an URGENT: Product Corrective Action letter to all affected customers. The letter provided customers with an explanation of the problem identified and actions to be taken. The letter instructs customers to share this information with their laboratory staff and retain a copy as part of their laboratory Quality System documentation. In addition, the letter states that if the affected product was further distributed to provide a copy of the letter to them. Customers were also asked to complete and return the enclosed Response Form. For any questions contact Customer Sup |
| Quantity | 3278 total (3083 in US, 195 in Canada) |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.