Health product recall

AmniSure ROM Test (2020-03-24)

Starting date:
March 24, 2020
Posting date:
April 15, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72719

Last updated: 2020-04-15

Affected Products

AmniSure ROM Test

Reason

Qiagen is issuing an urgent correction notice pertaining to the AmniSure ROM Test Kits. An image on the associated polybag contains an incorrect rinse time of 30 (thirty) seconds. The correct rinse time is 1 (one) minute.

Affected products

AmniSure ROM Test

Lot or serial number

563011195

Model or catalog number

FMRT-1-25

Companies
Manufacturer

Qiagen Sciences LLC

19300 Germantown Rd.

Germantown

20874

Maryland

UNITED STATES