Z-1783-2010

Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454...

Name: Z-1783-2010 Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454...
Creator: Nova Biomedical Corporation
Published: 2010-02-12
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2010-02-12 / Terminated / root cause: manufacturing process

FDA source

Nova Biomedical Corporation began a recall of Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care... on 2010-02-12. The reason FDA records is "Glucose strips report low glucose results". 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-1783-2010
Status: Terminated
Initiated: 2010-02-12
Posted: 2010-06-10
Terminated: 2011-07-22
Recalling firm: Nova Biomedical Corporation
Product: Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Glucose strips report low glucose results
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682.
Quantity in commerce: 392 Cases (1800 strips each)
Distribution: Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.
Product codes and lots: Lot Number: 0309019249, Expiration Date: 1/31/2011.

Product code CGA

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)