Abbott Diabetes Care, Inc.

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

Abbott Item #70684-01; Lot No. 01M0248; Kit Serial numbers BAAH220-80089, BAAH220-81000, Tx Serial Numbers AAAH187-80187, AAAH187-80845.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott Item Number 70684-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

Abbott Item # 70684-02 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1018 or 01M1028 or 01M1038 or 01M1148 or 01M1178 or 01M1218 or 01M1288 or 01M1368 or 01M1488 or 01M1618 or 01M1708 or 01M1898 or 01M1918 or 01M2108 or 01M2198 or 02M1038 or 02M1048 or 03M1058. Kit Serial numbers beginning with: BAAH 093 or BAAH 107 or BAAH 156 or BAAH 162 or BAAH 186 or BAAH 200 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 275 or BAAH 290 or BAAH 299 or BAAH 341 or BAAH 353 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 283 or AAAH 296 or AAAH 354, and followed by a five (5) digit number.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING ORANGE, Abbott Item Number 70684-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.