The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0486-2014·Announced 2013-12-25

Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Low Results

Abbott Diabetes Care is recalling certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Abbott Diabetes Care, Inc. is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips. The recall involves 141,219 cartons distributed worldwide, including the United States, Puerto Rico, and various international markets. The affected products are intended for in vitro diagnostic testing to measure glucose in capillary whole blood.

The recall was initiated because certain lots of these test strips produce erroneously low blood glucose results when used with FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters, or the FreeStyle blood glucose meter built into the OmniPod system. The source text states that erroneously low results that are not recognized may pose significant risks to the user's health.

Consumers and healthcare professionals who have purchased these specific lots should stop using the test strips. The recall covers multiple part numbers and lot numbers with expiration dates ranging from May 2014 to March 2015. Users should check their product packaging against the specific lot numbers and expiration dates listed in the official recall notice to determine if their product is affected.

The recalled product

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…
Manufacturer
Abbott Diabetes Care, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
141,219

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Part number: 71026-70
  • Lot number: 1281732
  • Exp. date: 2014/05
  • Lot number: 1283603
  • Exp. date: 2014/06
  • Part number: 70827-71: Lot number: 1363015
  • Exp. Date: 2014/11
  • Lot number: 1363109
  • Exp. Date 2014/11: Lot number: 1365921
  • Exp. Date 2014/12
  • Part number 70827-72: Lot number: 1366006 Exp. Date : 2014/12
  • Lot number 1366111
  • Exp. Date: 2014/12
  • Lot number 1366337
  • Lot number: 1366515
  • Exp Date: 2014/12
  • Part number 70822-71
  • Lot number 1283345: Exp. Date: 2014/05
  • Lot number 1365920
  • Lot number 1365934

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Abbott Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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