Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests

Class I - Dangerous

🏥 Medical Devices Recalled: April 28, 2017 Exact Sciences Diagnostic Equipment

What Should You Do?

Check if you have this product:
Equipment ID / Serial Number: MIX-0051 / MX00002051, MIX-0052 / MX00002032, MIX-0053 / MX00002028, MIX-0054 / MX00002052, MIX-0055 / MX00002043, MIX-0056 / MX00002040, MIX-0057 / MX00002050, MIX-0058 / MX00002036, MIX-0059 / MX00002027, MIX-0060 / MX00002015, MIX-0061 / MX00002016, MIX-0063 / MX00002039, MIX-0064 / MX00002033, MIX-0065 / MX00002053, MIX-0066 / MX00002014,
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Exact Sciences Corporation
Reason for Recall:: Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests

Product Codes/Lot Numbers:

Equipment ID / Serial Number: MIX-0051 / MX00002051, MIX-0052 / MX00002032, MIX-0053 / MX00002028, MIX-0054 / MX00002052, MIX-0055 / MX00002043, MIX-0056 / MX00002040, MIX-0057 / MX00002050, MIX-0058 / MX00002036, MIX-0059 / MX00002027, MIX-0060 / MX00002015, MIX-0061 / MX00002016, MIX-0063 / MX00002039, MIX-0064 / MX00002033, MIX-0065 / MX00002053, MIX-0066 / MX00002014,

Distribution:

Distributed in: US, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2219-2017