Reported Dec 25, 2013 · Terminated
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood…
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?
- FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips
- for Institutional Use only 50 countUPC 6 99073 70792 5 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
- Part number 12050-21Lot
- number1285007 Exp
- date
2014/06Part number 70792-20 (instuitional
- use) Lot number
1373262Exp. Date 2015/02
- Amount recalled
- 141,219 cartons for human use - all lot numbers
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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