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Serious riskFDA DeviceClass I

FreeStyle Libre 3 Plus sensors recalled for possible incorrect lows

Abbott has recalled certain FreeStyle Libre 3 Plus glucose sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup can result in the sensor showing incorrect low blood sugar readings when your actual glucose is normal or higher. The recall affects specific lot numbers with expiration date of 01/31/2026.

From the FDA notice · Read the official notice ↗ · All Abbott recalls

What to do

  1. Check if your sensor serial number matches the recall list on the FDA website or Abbott's recall notice
  2. Stop using the sensor immediately if it matches an affected lot
  3. Contact Abbott customer service or your healthcare provider for a replacement sensor
  4. In the meantime, use fingerstick testing or another glucose monitoring method as directed by your doctor
  5. Do not rely on low glucose alerts from an affected sensor
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 4 products — see all of them.

Details

Units affected
258,913 sensors
Illnesses reported
None reported
Manufactured in
1360 S Loop Rd, Alameda, CA, United States
Classification
Class I
Recall number
Z-1022-2026

In the FDA's words

Description
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results Model Number: 78769-01 UDI-DI Code: 00357599843014 Product Expiry Date: 01/31/2026 Kit Pack Lot Number: T60003166 Pack Serial Numbers: 0HPCMWH9Y 0HPCMWHAV 0HPCMWHA9 0HPCMWHA0 0HPCMWHAK 0HPCMWHAR 0HPCMWHAU 0HPCMWHAJ 0HPCMWHAG 0J8A08TUA 0HPCMWHAQ 0HPCMWHAF 0J8A08TTZ 0J8A08TUD 0HPCMWHAT 0J8A08TTY 0J8A08TU1 0HPCMWHAZ 0J8A08TUC 0J8A08TU0 0HPCMWHC9 0HPCMWHAX 0J8A08TUE 0J8A08TU2 0HPCMWHAM 0J8A08TUG 0HPCMWHAW 0HPCMWHAL 0J8A08TU5 0J8A08TUJ 0HPCMWHAY 0J8A08TU3 0J8A08TU8 0HPCMWHC4 0J8A08TUH 0J8A08TU7 0HPCMWHL8 0J8A08TW4 0HPCMWHLL 0HPCMWHL9 0J8A08U3T 0J8A08U45 0J8A08TW3 0J8A08U3U 0J8A08U3Q 0J8A08U3N 0J8A08TW5 0J8A08U3R 0J8A08U3C 0J8A08U3L 0J8A08TW1 0J8A08U39 0J8A08U31 0J8A08U3M 0J8A08U3A 0J8A08U2Q 0J8A08U2Z 0J8A08U3K 0J8A08U2N 0J8A08U3H 0J8A08U30 0J8A08U2P 0J8A08U36 0J8A08U43 0J8A08TV2 0J8A08U34 0J8A08U2W 0J8A08U3G 0J8A08U35 0J8A08U2K 0J8A08U2U 0J8A08U3E 0J8A08U38 0J8A08U2H 0J8A08U2L 0J8A08U2V 0J8A08U2J 0HPCMWHKW 0J8A08U2Y 0J8A08U2X 0HPCMWHL5 0HPCMWHKU 0J8A18G45 0J8A18G29 0J8A18G20 0J8A18G3W 0J8A18G3Y 0J8A18G2C 0J8A18G22 0J8A18G1Z 0J8A18G2A 0J8A18FWA 0J8A18G40 0J8A18G21 0HPD38KT2 0HPD38KTF 0HPD38KTG 0HPD38KTR 0HPD38KTH 0HPD38KTT 0HPD38KTJ 0JH6L4FC0 0JH6L4FAP 0JH6L4FC1 0JH6L4FAQ 0HPD38KRW 0JH6L4FAR 0HPD38KT8 0HPD38KT7 0HPD38KTL 0HPD38KTK 0HPD38KTM 0HPD38KTA 0HPD38KTN 0HPD38KTC 0HPD38KTP 0HPD38KTD 0JH6L4FAV 0JH6L4FC6 0JH6L4FAW 0JH6L4FC2 0JH6L4FAX 0JH6L4FC3 0HPD38KR5 0J8A18G1R 0J8A18G1K 0HPD38KRK 0J8A18G1T 0J8A18G1V 0J8A18G1H 0J8A18G1L 0J8A18G1W 0J8A18G82 0J8A18G8R 0J8A18G1J 0J8A18G1U 0J8A18G85 0J8A18G8U 0J8A18G8Q 0J8A18G84 0J8A18G88 0J8A18G1E 0J8A18G1P 0J8A18G1C 0J8A18G1F 0J8A18G1Q 0JH6L4FAT 0JH6L4FC4 0JH6L4FAU 0HPD38KUV 0HPD38KUJ 0HPD38KUW 0HPD38KUX 0HPD38KUL 0HPD38KUY 0HPD38KUM 0HPD38KUZ 0HPD38KUN 0JH6L4FC7 0J8A18GLT 0JH6L4FC8 0JH6L4Q11 0JH6L4Q0Y 0JH6L4Q19 0JH6L4Q0Z 0JAEYKEHA 0JAEYKEHQ 0JAEYKEHN 0JAEYKEHC 0JAEYKEHE 0JAEYKEH5 0JAEYKEHR 0JAEYKEHF 0JAEYKERA 0JAEYKEH3 0JAEYKEHP 0JAEYKEHD 0JAEYKERD 0JAEYKER3 0JAEYKEH4 0JAEYKERC 0JAEYKERF 0JAEYKEHK 0JAEYKER2 0JAEYKERE 0JAEYKEH8 0JAEYKER4 0JAEYKEHL 0JAEYKEH9 0JAEYKERG 0JAEYKER6 0JAEYKEH6 0JAEYKERJ 0JAEYKER9 0JAEYKERH 0JAEYKERL 0JH6L4Q0V 0JAEYKER8 0JAEYKERK 0JH6L4Q0J 0JH6L4Q0T 0JH6L4Q0X 0JH6L4Q0K 0JH6L4Q0G 0JAEYKET8 0JH6L4Q0U 0JH6L4Q0H 0JAEYKETK 0JAEYKETA 0JH6L4Q0R 0JH6L4Q0F 0JAEYKETM 0JH6L4Q0P 0JAEYKET9 0JAEYKETL 0JH6L4Q0D 0JH6L4Q0M 0JH6L4Q0Q 0JH6L4Q0E 0JH6L4Q0A 0JAEYKETE 0JH6L4Q0N 0JH6L4Q0C 0JAEYKETQ 0JH6L4Q0L 0JH6L4Q09 0JAEYKETT 0JAEYKETD 0JAEYKETF 0JAEYKETR 0JAEYKETP 0JAEYKERN 0JAEYKETC 0JAEYKETN 0JAEYKERZ 0JAEYKERQ 0JAEYKERM 0JAEYKERY 0JAEYKET1 0JAEYKETW 0JH6L4M8M 0JH6L4M8Z 0JH6L4M93 0JH6L4M02 0JH6L4M8P 0JH6L4M91 0JH6L4M8C 0JH6L4M81 0JH6L4M8R 0JH6L4M8A 0JH6L4M88 0JH6L4M03 0JH6L4M01 0JH6L4M86 0JH6L4M9F 0JH6L4M04 0JH6L4M89 0JH6L4M9H 0JH6L4M97 0JH6L4M94 0JH6L4M9G 0JH6L4M9K 0J8A18NCP 0JH6L4M96 0JH6L4M9J 0JH6L4M8E 0JH6L4M83 0JH6L4M98 0JH6L4M8D 0JH6L4M9L 0JH6L4M9A 0JH6L4M82 0JH6L4M8F 0JH6L4M9N 0JH6L4M9D 0JH6L4M99 0JH6L4M9M 0JH6L4M9Q 0J8A18NCW 0JH6L4M9C 0JH6L4M9P 0JH6L4N2D 0JH6L4N22 0JH6L4N25 0JH6L4N2E 0HPD2HD46 0JH6L4N23 0HPD2HD47 0JH6L4N2C 0JH6L4N21 0HPD2HD3V 0HPD2HCW0 0JH6L4N29 0JH6L4N1Z 0HPD2HD49 0JH6L4N2A 0JH6L4N27 0JH6L4N1X 0JH6L4N20 0JH6L4N28 0HPD2HD3Z 0HPD2HD3M 0JH6L4N1Y 0HPD2HD40 0HPD2HD44 0HPD2HD3Q 0HPD2HD3N 0HPD2HCV0 0HPD2HCVC 0HPD2HD3T 0HPD2HD41 0HPD2HCV3 0HPD2HCVE 0HPD2HD3P 0HPD2HCV1 0HPD2HCV5 0HPD2HCVG 0HPD2HCVD 0HPD2HCV4 0JH6L4LRF 0J8A18N3X 0J8A18N3E 0JH6L4LRT 0J8A18N3Y 0J8A18N3R 0J8A18N3H 0J8A18N3F 0J8A18N3W 0JH6L4LRU 0JH6L4LT5 0JH6L4LRW 0JH6L4LT7 0JH6L4LT4 0JH6L4LRV 0JH6L4LRY 0JH6L4LTR 0JH6L4LT6 0JH6L4LRX 0JH6L4LTG 0JH6L4LR2 0JH6L4LT8 0JH6L4LTF 0JH6L4LRZ 0JH6L4LTA 0J8A18N3D 0J8A18N3Q 0JH6L4LT1 0JH6L4LTD 0JH6L4LT9 0JH6L4LT0 0JH6L4LT3 0JH6L4LTC 0JH6L4LT2 0JH6L4LTM 0JH6L4LTU 0JH6L4LTE 0JH6L4LTL 0J8A18N1L 0J8A18N1F 0JH6L4LW6 0JH6L4M49 0J8A18N1N 0J8A18N1G 0JH6L4LW4 0J8A18N1M 0J8A18N1Q 0J8A18N22 0J8A18N21 0J8A18N1P 0JH6L4LWA 0J8A18N1H 0JH6L4LWC 0J8A18N1R 0J8A18N1X 0JH6L4LW1 0J8A18N1U 0J8A18N1Z 0JH6L4LVZ 0J8A18N1T 0J8A18N1W 0J8A18N27 0J8A18N1Y 0J8A18N1V 0J8A18N2F 0J8A18N24 0J8A18N20 0J8A18N2E 0J8A18N2H 0J8A18N26 0J8A18N23 0J8A18N2G 0JH6L4LTQ 0JH6L4LU0 0J8A18N25 0J8A18N2J 0JH6L4LTN 0JH6L4LTY 0J8A18N2R 0J66PK328 0J66PK32N 0J66PK32M 0J66PK326 0J66PK32L 0HPD0KMUV 0HPD0KMUJ 0HPD0KMUQ 0HPD0KMUG 0J66PK2V9 0J66PK335 0J66PK2VE 0J66PK334 0J66PK33F 0J66PK333 0HPD0KMUW 0J66PK332 0HPD0KMUL 0HPD0KMUN 0HPD0KMUM 0J66PK33D 0HPD0KMUT 0J66PK33A 0J66PK331 0J66PK339 0J66PK338 0J66PK337 0J66PK32Y 0J66PK32X 0HPD0KMVA 0HPD0KMVC 0HPD0KMV3 0JH6L4KUK 0J8A18M86 0JH6L4KUG 0JH6L4KV0 0JH6L4KV2 0JH6L4KUJ 0JH6L4KUZ 0JH6L4KV7 0J8A18M8C 0JH6L4KUL 0JH6L4KV1 0J8A18M0A 0JH6L4KUT 0J8A18M0C 0JH6L4KUN 0JH6L4KUQ 0J8A18M8D 0JH6L4KUM 0JH6L4KUW 0JH6L4KVJ 0JH6L4KUP 0JH6L4KVD 0JH6L4KV4 0JH6L4KUR 0JH6L4KU
Hazard
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

4 products in this recall

Abbott FreeStyle Libre 3 sensors recalled for false low readings

Abbott is recalling four FreeStyle Libre 3 and Libre 3 Plus glucose sensor models, about 3 million sensors in total. A manufacturing problem may cause carbon buildup in the sensor, which can lead to incorrect low glucose results. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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