Z-1546-05

SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova...

Name: Z-1546-05 SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova...
Creator: CHdiagnostics
Published: 2005-03-14
License: https://open.fda.gov/license/

Chdiagnostics, LLC / initiated 2005-03-14 / Terminated / root cause: manufacturing process

FDA source

CHdiagnostics began a recall of SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not... on 2005-03-14. The reason FDA records is "A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1546-05
Status: Terminated
Initiated: 2005-03-14
Posted: 2005-09-15
Terminated: 2007-01-23
Recalling firm: Chdiagnostics, LLC
Product: SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots.
Quantity in commerce: 43,138 vials
Distribution: AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom.
Product codes and lots: Lot numbers: 407061, 4071601, 4071901, 4071902, 4072001, 4072002, 4072201, 4072202, 4072801, 4072802, 4072901, 4072902, 4073001; 4080301, 4080302, 4080303, 4080401, 4080402, 4080601, 4081101, 4081102, 4081601, 4081901, 4082001, 4082002, 4082301, 4082501, 4082502, 4082701, 4083101, 4083102, 4090101, 4090201, 4091601, 4091702, 4092101, 4092201, 4092301, 4092401, 4092701, 4092801, 4092901, 4100101, 4100401, 4100402, 4100501, 4100601, 4101101, 4101201, 4101301, 4101401, 4101801, 4102201, 4102502, 4102601, 4102701, 4102801, 4102901, 4110401, 4110501, 4111101, 4111601 and 4111602.

Product code LFR

K032076Class IISenova(r) Blood Glucose MonitorChdiagnostics, LLC / cleared 2003-09-30

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)