FDAClass IMay 15, 2013

FreeStyle InsuLinx Blood Glucose Monitoring System: For recall

FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes…

Why was FreeStyle InsuLinx Blood Glucose Monitoring System: For recalled?

AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.

Product
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes…
Recalling firm
Abbott Diabetes Care, Inc.
Quantity
335,273 meters; 209,336 remain at firm.
Distribution
Nationwide Distribution
Recall date
May 15, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls