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FreeStyle Blood Glucose Test Strips recallZ-0485-2014 · Abbott Diabetes Care, Inc. · initiated Nov 18, 2013

Class I Terminated All recalls posted in December 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

Abbott Diabetes Care sent an Urgent Product Recall letter in November 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who were affected were instructed to take the following steps: Call Abbott Diabetes Care Customers Service immediately at 1-888-736-9869 for replacement of the affected product. While waiting for replacement strips to arrive, use an alternate method to measure their blood glucose. If only test strips available to customers were from affected lots, customers should not stop testing their blood glucose. Customers were instructed to dispose of the test strips in accordance with their local and state disposal regulations. Customers with questions were instructed to call Abbott Diabetes Care Customers Service at 1-888-736-9869. For questions regarding this recall call 510-239-2775. Abbott issued a press release at the request of CDRH on november 27, 2013.

Recall details

Recall number
Z-0485-2014
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Nov 18, 2013
Posted by the FDA
Dec 17, 2013
Recalling firm
Abbott Diabetes Care, Inc.
Quantity
141,219 cartons for human use - all lot numbers
Product code
NBW
FDA submissions
K092602
Distribution
Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**

Product description

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 count: UPC 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.

Code information (models, lots, serial numbers)

Part number 12050-21: Lot number: 1285007 Exp. date: 2014/06; Part number 70792-20 (instuitional use) Lot number: 1373262, Exp. Date 2015/02

Other devices under the same FDA submission

5 devices cleared under K092602 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 66886).

Sources and updates

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