Recall Z-1253-2017 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Phadia US Inc
EliA Sample Diluent, Article number, 83-1023-01
| Date | Feb 24, 2017 (initiated Jan 30, 2017) |
| Status | Terminated |
| Reason | Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate. |
| Root cause | Under Investigation by firm |
| Action | Phadia AB, part of Thermo Fisher Scientific, is voluntarily recalling EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C, written notices were mailed via FedEx on 01/30/2017. There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles for the below mentioned product and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or br |
| Quantity | 5957 |
| Distribution | Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061165 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 Sweden Diagnostics (Us), Inc., Aug 3, 2006 |