Recall Z-0616-03 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Thermo Biostar, Incorporated
Chlamydia OIA. For in vitro diagnostic use.
| Date | Mar 6, 2003 (initiated Feb 7, 2003) |
| Status | Terminated |
| Reason | Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample. |
| Root cause | Other |
| Action | All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003. |
| Quantity | 56 units |
| Distribution | Nationwide, and to France, New Zealand and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951010 | CHLAMYDIA OIA Biostar, Inc., Oct 7, 1995 |