Recall Z-0513-2020 ยท CGA Glucose Oxidase, Glucose
Medline Industries Inc
EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
| Date | Sep 18, 2019 |
| Status | Terminated |
| Reason | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. |
| Root cause | Packaging process control |
| Action | Medline Industries, Inc. notified customers on about 09/18/2019, via "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter. Customers were informed that the heat activated adhesive used to seal the foil pouch was not fully cured during the manufacturing process. As a result, an incomplete seal and premature expiration of the individually packaged Blood Glucose Test Strips has occurred. Inspection using EVENCARE G3 control solution and unused Blood Glucose Test Strips, from the affected lot, has shown that the test strips can produce inaccurate blood glucose readings. Instructions included to i |
| Quantity | 761 boxes (38,050 foil pouches) |
| Distribution | Nationwide distribution to CA, CT, GA, ID, IL, IN, KS, MA, MI, MN, MO, MS, NV, OH, OR, SC, TN, TX, UT, WA, WI, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120448 | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL Apex BioTechnology Corp., Apr 6, 2012 |