FreeStyle Lite Blood Glucose Test Strips — Class I medical device recall Z-0486-2014
Terminated recall by Abbott Diabetes Care, Inc., reported 2013-12-25, distributed nationwide. Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose r
| Recall number | Z-0486-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diabetes Care, Inc., Alameda, CA, United States |
| Recall initiated | 2013-11-18 |
| Classified | 2013-12-17 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2015-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, DE, DK, EG, FI, FR, GB, IE, IL, JM, LU, NL, NO, SE |
| Quantity | 141,219 cartons |
| UPC / GTIN / UDI-DI | 00699073708199, 00699073708229, 00699073708274, 00699073710260 |
| Lot numbers | 1281732, 1283345, 1283603, 1350414, 1363015, 1363109, 1363321, 1365056, 1365920, 1365921, 1365934, 1366006, 1366111, 1366337, 1366347, 1366515, 1367917, 1374907, 2014/05, 2014/06, 2014/07, 2014/11, 2014/12, 2015/03 |
| Model numbers | 70819-70, 70822-71, 70822-72, 70827-71, 70827-72, 71026-70 |
Product
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Reason for recall
Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0486-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.