Z-0605-06

FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360...

Name: Z-0605-06 FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360...
Creator: Abbott Diabetes Care, Inc.
Published: 2006-02-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-02-17 / Terminated

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; Part Number... on 2006-02-17. The reason FDA records is "The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0605-06
Status: Terminated
Initiated: 2006-02-17
Posted: 2006-03-15
Terminated: 2011-01-20
Recalling firm: Abbott Medical
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
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 0522524, 0526329, 0526326, 0529324, 0532203, 0533607, 0533641, 0534362, 0534404, 0534421, 0601135, 0601165, 0601608, 0601661

Product code JJX

K013147Class IGlucose Control Solution for Therasense FreestyleBionostics, Inc. / cleared 2001-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)