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FreeStyle Libre 14 day
ABBOTT DIABETES CARE INC · Model 71938 · UDI-DI 00357599002008
PZE
Prescription
0
510(k) clearances
133,421
Adverse events (13 deaths)
3
Recalls
11
Facilities
Description
FreeStyle Libre 14 day Reader Kit US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-13 | Abbott Diabetes Care, Inc. | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use rea |
| 2023-02-13 | Abbott Diabetes Care, Inc. | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use rea |
| 2021-03-16 | Cardinal Health Inc. | Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.