Abbott Glucose Test Strip Recall Classified as Class 1 Recall

The FDA has classified an Abbott glucose test strip recall as a Class 1 medical device recall, due to the risk that the test strips may provide inaccurate blood sugar readings and potentially cause diabetes patients to suffer a serious injury or even death. 

The diabetes glucose test strip recall was originally announced on December 22, when Abbott sent a letter to customers notifying them of the problem. The Class 1 recall designation means that the FDA believes that these products pose a reasonable probability of causing serious injury or death.

The recall affects the Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliON Ultima glucose test strips made by Abbott. The test strips were manufactured between January and September 2010, and are used with monitoring systems of the same names. The monitoring systems themselves are not being recalled.

Did You Know?

Ticketmaster Data Breach Impacts Millions of Customers

A massive Ticketmaster data breach exposed the names, addresses, phone numbers, credit card numbers and other personal information of more than 560 million customers, which have now been released on the dark web. Lawsuits are being pursued to obtain financial compensation.

Learn More

According to Abbott, the problem may be caused by longer than expected blood fill times and could also be affected by the age of the blood strip and how it was stored.

Abbott and the FDA recommend that customers using the affected strips discontinue using them and contact Abbott for free replacement strips. The Abbott letter contains detailed instructions on what to do if the customer has no access to unaffected strips.

Affected customers can receive more information by calling Abbott Diabetes Care customer service at 1-800-448-5234.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Zimmer Biomet CPT Hip System Linked to Increased Risk of Thigh Bone Fractures, FDA Warns
Zimmer Biomet CPT Hip System Linked to Increased Risk of Thigh Bone Fractures, FDA Warns (Posted today)

The FDA has issued a safety communication warning that Zimmer Biomet CPT hip system femoral stems may increase the risk of femur fractures, calling for doctors to avoid its use when possible.

Change Healthcare Data Breach Lawyers Meeting Today With MDL Judge For Initial Status Conference
Change Healthcare Data Breach Lawyers Meeting Today With MDL Judge For Initial Status Conference (Posted yesterday)

The judge presiding over all Change Healthcare lawsuits filed in federal court is holding the first status conference of the litigation, which is expected to grow significantly as Change Healthcare data breach letters continue to be sent to impacted customers.

Angiodynamics LifePort Lawsuit Filed Over Risk of the Port Catheters Failing, Causing Severe Injury
Angiodynamics LifePort Lawsuit Filed Over Risk of the Port Catheters Failing, Causing Severe Injury (Posted 2 days ago)

Complaint comes as a panel of federal judges are scheduled to hear oral arguments later this month, to determine whether all AngioDynamics port catheter lawsuits filed in U.S. District Courts nationwide should be centralized before one judge.