FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; Part Number: CAT70676-01
- Recall number
- Z-0605-06
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; Part Number: CAT70676-01
- Status
- Terminated
- Initiated
- 2006-02-17
- Posted
- 2006-03-15
- Terminated
- 2011-01-20
- Reason
- The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
- Root cause
- Other
- Action
- On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.
- Quantity
- 900
- Distribution
- 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.
- Lot, serial or model codes
- Lot Numbers: 0522524, 0526329, 0526326, 0529324, 0532203, 0533607, 0533641, 0534362, 0534404, 0534421, 0601135, 0601165, 0601608, 0601661
- 510(k) numbers
- ["K013147"]
- PMA numbers
- not on file
- Product code
- JJX
- Firm FEI
- 3002803444
- Firm city
- Alameda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28