Device Recall FreeStyle

All lot numbers beginning with R and all lot numbers T-G158-62981 and below are included.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.

FreeStyle FLASH Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

For lot numbers beginning with A, B, C, D, G, H, K, and M, all lot numbers are included. All lot numbers from V-G157-31584 and below are included, and also all lot numbers Y-G018-32983 and below are included in the recall.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.

FreeStyle Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

N/A. Product is a software package.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Software, distributed from website via clicking through an agrement to use only for informational purposes, and not as a substitute for professional medical advice treatment or diagnosis.

FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.

All lots, including: FC0010, FC0012, FC0013, FC0014, FC0015, FC0016, FC0017, FC0020, FC0019, FC0018, FC0021, FC0022, FC0023, FC0026, FC0024, FC0025, FC0027, FC0028, FC0029, FC0030, FC0031, FC0032, FC0033, FC0034, FC0036

Clinical Chemistry and Clinical Toxicology Devices

2

No

The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; || Part Number: 70672-01; || Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Lot Numbers: 0522524, 0526329, 0526326, 0529324, 0532203, 0533607, 0533641, 0534362, 0534404, 0534421, 0601135, 0601165, 0601608, 0601661

Clinical Chemistry and Clinical Toxicology Devices

1

No

The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; || Part Number: CAT70676-01