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

• Reason
• Affected products

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