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

Products covered by this recall
#Product as published
1FreeStyle Lite Blood Glucose Test Strips
2For in vitro diagnostic testing. 50 count
3100 count Product of Ireland
4UPC 6 99073 70819 9
550 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 / numberProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 3, 2015 · Data as of Sep 19, 6:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.