Recall Z-1592-2024 ยท OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1
ACTIM OY
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
| Date | Apr 17, 2024 (initiated Nov 23, 2023) |
| Status | Open, Classified |
| Reason | Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result. |
| Root cause | Under Investigation by firm |
| Action | Actim Oy issued a MEDICAL DEVICE RECALL notice to its sole distributor on 11/23/2023 via email. The notice explained the issue, potential risk, and requested that users refrain from using surgical lubricants when collecting the vaginal specimen and that vaginal specimens do not contain significant amounts of personal lubricant from patient's recent personal use. The instructions for use will be updated according to the latest test results of surgical and personal lubricant interference. In the interim, a separate note will be included in the test kit regarding the correction of the interfer |
| Quantity | 6471 kits |
| Distribution | US Nationwide distribution in the state of Connecticut. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123986 | ACTIM PROM Alere Scarborough, Inc., Jan 9, 2014 |