Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3

Reason: Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.

Code information: REF/UDI-DI/Lot: MMT-7040A/20763000413389/HG72B2C, HG72CQQ, HG73VB7, HG73VC8, HG73VFT, HG73WFR, HG7441E, HG745F9, HG7486X, HG74AJ1, HG74SUR, HG74T9Q, HG74U36, HG78LMS, HG79Y9U; MMT-7040C1/00763000555276, 00763000413392, 20763000413396, 20763000555270, 20763000712475, 00763000712471/F1323, F1923, G0323, G1723, G2023, G2623, G2923, HG6RV7S, HG6TGNU, HG6TJ2Y, HG6TW97, HG6TWVU, HG6UNF2, HG6V8NN, HG6VB8S, HG6VNX3, HG6WNE1, HG6XFPR, HG6XH54, HG6XQCG, HG6XZJX, HG6Y0W1, HG6Y3QN, HG6YEK6, HG6YFAF, HG6YFHL, HG6YJAR, HG6YJBD, HG6YNGD, HG6Z7N5, HG6ZARN, HG7038Y, HG70CW5, HG70DAM, HG70JSU, HG70LRC, HG70QWA, HG71VMZ, HG72DB5, HG72G9C, HG72NV9, HG72R1P, HG72RBD, HG72SE3, HG72TPT, HG72TRV, HG72V3J, HG72ZFP, HG7340A, HG73EJX, HG73RNR, HG745SV, HG747E3, HG7480Q, HG749N6, HG74F93, HG75TSX, HG75XA1, HG76HFH, HG76RYY; MMT-7040C2/20763000555287/HG6RC39, HG6RXB5, HG6T4T7, HG6T8RV, HG6TJ2Y, HG6WKZU, HG6WLKS, HG6XFPR, HG6XH54, HG6XLSD, HG6XNH3, HG6Y5C6, HG6Z1X5, HG713AK, HG73EGX, HG73EJX, HG73FJP, HG73Q24, HG73QPM, HG73RNR, HG7619X, HG764J9, HG76CWC, HG77FMK; MMT-7040C3/20763000555294/HG6XNH3, HG73RNR; MMT-7040D1/00763000413484/HG6THY1, HG6V7VV; MMT-7040D2/00763000413491/HG6TL44; MMT-7040MA/20763000519692/HG74460; MMT-7040QC1/00763000555313, 20763000555317/HG6WT9A, HG6WUGE, HG73PH3; MMT-7040QC2/20763000555324, 763000555320/HG6WT9A; MMT-7040QC3/20763000555331/HG6WT9A

Distribution pattern: Worldwide - US Nationwide distribution including in the states of PR, AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Austria, Belgium, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Liechtenstein, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.