Recall Z-1440-06 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
Beckman Coulter Inc
UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
| Date | Aug 26, 2006 (initiated May 15, 2006) |
| Status | Terminated |
| Reason | Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results. |
| Root cause | Other |
| Action | A Product Correction Action (PCA) letter was sent the week of May 15, 2006 to all Unicel DxC customers informing them not to leave any Lithium reagent cartridge onboard a UniCel DxC System past 14 days. They also were instructed to complete and return the enclosed response form. The Letter was sent by US Mail. |
| Quantity | 524 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.