Recall Z-1592-2024— ACTIM OY

Name: FDA recall Z-1592-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-23

Class II · Ongoing

Class II FDA medical device recall by ACTIM OY, initiated 2023-11-23. It names one FDA 510(k) clearance: K123986. Product: Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane. 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..

Recalling firm: ACTIM OY
Classification: Class II
Status: Ongoing
Initiated: 2023-11-23
Firm location: Espoo, Finland

510(k) clearances named in this recall

1 on FDA's record

K123986 — ACTIM PROMAlere Scarborough, Inc.·cleared 2014-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.