URGENT NOTICE ABOUT RECALLED BLOOD GLUCOSE TEST STRIPS

                                                 October 11, 1995

    URGENT NOTICE ABOUT RECALLED BLOOD GLUCOSE TEST STRIPS  


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


	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