Recall Z-1276-2018 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Phadia Ab
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
| Date | Nov 20, 2017 |
| Status | Terminated |
| Reason | We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU). |
| Root cause | Software design |
| Action | An urgent recall notification was issued to customers in November of 2017, and informs all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU). For further questions, please call (269) 492-1940. |
| Quantity | 2307 |
| Distribution | US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151029 | Phadia Prime Phadia AB, Jan 19, 2016 |