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U.S. Department of Health and Human Services

Medical Devices

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Urgent Notice About Recalled Blood Glucose Test Strips

This is an archived document and is no longer current information.

October 11, 1995

 

Dear Health Care Professionals:

A number of blood glucose test strips were recently recalled by the manufacturer
because they may give inaccurate readings, both high and low, posing a potentially
serious health risk to users.

The strips were recalled and a press release issued by the manufacturer. However,
FDA and the manufacturer have recently found recalled strips in some retail outlets and
health care facilities, such as nursing homes. The recalled test strips may also be in
home medicine cabinets.

Retailers are hereby notified by FDA in conjunction with Diagnostic Solutions,
Inc., that notifications concerning recalled blood glucose test strips should not
be ignored.

RECOMMENDED ACTIONS

FDA and the manufacturer are urging that pharmacies and health care facilities:

  • check inventories and immediately remove the indicated test strips
    from their shelves, and
  • post the attached Important Notice where it is visible to consumers.
HOW TO IDENTIFY THE PROBLEM TEST STRIPS

The recalled test strips, all manufactured by Diagnostic Solutions, Inc., were sold under
nineteen brand names, as listed below. All the recalled test strips have lot numbers
beginning with 30, 31, 41, or 43 and expiration dates ranging from February 1993 to
December 1996. Other lot numbers of these brands are not affected.

 

Brand Names

BRITE-LIFE HEALTH MART QUICK CHECK ONE
BROOKS LONGS QUICK CHECK 3
BROOKS 1 MK (MEDICAL) RELIEF PLUS
FAMILY PHARMACY PERRY 1 RELIEF PLUS ONE
FULL VALUE PERRY HEALTH CARE TOP CARE
GIANT EAGLE QUALITEST 3 VALU-RITE
GOOD NEIGHBOR    

 

Diagnostic Solutions, Inc. has improved the manufacturing process to correct the
problem and the company is now manufacturing new strips under these same brand
names. The new strips are sold in containers that look almost identical to those in
which the recalled test strips are packaged. Therefore, to identify the recalled test
strips, it is important to examine the lot numbers.

OTHER RECOMMENDED ACTIONS

In the interest of safety to patients, who may still have the recalled strips in their homes,
FDA and the manufacturer are also asking that:

  • Health care facilities stop use of the recalled strips
  • Health care professionals display and disseminate the attached
  • Important Notice and advise patients to discontinue use of the recalled
    test strips, and
  • Organizations notify their members. (This document and the attached
    Important Notice may be reproduced.)

In the meantime, FDA will continue to monitor the effectiveness of the recall. It is
critical that all pharmacies complete the recall process that the company has initiated by
following the above recommendations.

Diagnostic Solutions, Inc., will replace the recalled test strips. For more information,
call 1-800-446-4374. This number is available to health care professionals and
consumers. The hours of operation are 8:00 a.m. to 4:00 p.m. Pacific Time/11:00 a.m.
to 7:00 p.m. Eastern Time.

Sincerely yours,

D. Bruce Burlington
Director
Center for Devices and Radiological Health
Food and Drug Administration

 

IMPORTANT NOTICE FOR USERS OF BLOOD GLUCOSE TEST STRIPS
 
WHAT'S THE PROBLEM?

Some brands of blood glucose test strips for use in blood glucose meters may give
incorrect high or low readings, leading to serious health problems. The
manufacturer has recalled the product and asked that these strips be taken off the
store shelves, but some people may still be using the recalled strips.

HOW DO I KNOW IF I HAVE THE RECALLED TEST STRIPS?

You must look at two things:

1. Check the brand.

 

The following brands were recalled:

BRITE-LIFE HEALTH MART QUICK CHECK ONE
BROOKS LONGS QUICK CHECK 3
BROOKS 1 MK (MEDICAL) RELIEF PLUS
FAMILY PHARMACY PERRY 1 RELIEF PLUS ONE
FULL VALUE PERRY HEALTH CARE TOP CARE
GIANT EAGLE QUALITEST 3 VALU-RITE
GOOD NEIGHBOR    

2. Check the lot number on the container. The recalled strips have lot numbers
beginning with 30, 31, 41, or 43. These brands are OK if they have other lot
numbers.

IF YOU ARE USING BLOOD GLUCOSE TEST STRIPS THAT MATCH THE
ABOVE BRANDS AND LOT NUMBERS:

1. Stop using these test strips and purchase a fresh supply.

2. Continue using your blood glucose meter with your new test strips and follow your doctor's instructions.

3. Contact your pharmacist or doctor if you have concerns or questions.

4. For information on how to exchange recalled test strips, call the manufacturer at
1-800- 446-4374 from 8:00 a.m. to 4:00 p.m. Pacific Time/11:00 a.m. to 7:00
p.m. Eastern Time.

October 27, 1995

 

If you have questions about this Notification, please contact FDA's  Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100