AmniSure ROM Test Strips (2018-05-18)

Starting date:

May 18, 2018

Posting date:

June 1, 2018

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-66934

• Reason
• Affected products

Affected products

AmniSure ROM Test (25)

Reason

Qiagen has determined that the AmniSure ROM Test Strips have the potential for not exhibiting a control line. A test strip that has no control line is an invalid test and a result cannot be interpreted.

Affected products