Reported Dec 25, 2013 · Terminated
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC…
Abbott Diabetes Care, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Diabetes Care, Inc. · 1360 S Loop Rd · Alameda, CA · 94502-7000
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | FreeStyle Lite Blood Glucose Test Strips |
| 2 | For in vitro diagnostic testing. 50 count |
| 3 | 100 count Product of Ireland |
| 4 | UPC 6 99073 70819 9 |
| 5 | 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. |
- Lot codes and dates
25 of 25 products
Products covered by this recall Model / number Product as published 71026-70— — Lot number: 1281732 — Exp. date: 2014/05 — Lot number: 1283603 — Exp. date: 2014/06 70827-71Lot number: 1363015, Exp. Date: 2014/11 — Lot number: 1363109, Exp. Date 2014/11: Lot number: 1365921, Exp. Date 2014/12 70827-72Lot number: 1366006 Exp. Date : 2014/12 — Lot number 1366111, Exp. Date: 2014/12 — Lot number 1366337 — Exp. Date: 2014/12 — Lot number: 1366515, Exp Date: 2014/12 70822-71— — Lot number 1283345: Exp. Date: 2014/05 — Lot number 1365920 — Exp. Date: 2014/12 — Lot number 1365934 — Exp. Date: 2014/12 70822-72Lot number: 1350414: Exp Date: 2014/07 — Lot number 1363321 - Amount recalled
- 141,219 cartons for human use - total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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