Recall Z-2200-2019 ยท DHR System, Test, Rheumatoid Factor
Hycor Biomedical Inc
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
| Date | Mar 19, 2018 |
| Status | Open, Classified |
| Reason | Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid. |
| Root cause | Labeling design |
| Action | On March 19, 2018, Hycor Biomedical sent a "Urgent Field Safety Notice" via Federal Express to consignees. The urgent field safety notices recommending the following steps to detect and minimize possible sample carryover: 1. Repeat testing of all patient samples for the HYTEC AUTOSTAT II RF assays when the negative control reports out of range. 2. Do not perform HYTEC AUTOSTAT II RF assays in batch mode. HYTEC AUTOSTAT II RF should be tested independently of all other autoimmune assays. 3. Performing testing in duplicate may assist in detecting potential carryover of high levels of IgG from |
| Quantity | 288 |
| Distribution | Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA Cogent Diagnotics , Ltd., Feb 3, 2000 |