Z-1154-2013Class II

Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)

Name: Z-1154-2013 Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
Creator: Nova Biomedical Corporation
Published: 2013-02-25
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2013-02-25 / Terminated / root cause: manufacturing process

FDA source

Nova Biomedical Corporation began a recall of Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only) on 2013-02-25. FDA classified it as Class II and gives the reason as "Glucose test strips reports no result message when tested". 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-1154-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-25
Posted: 2013-04-19
Terminated: 2014-09-26
Recalling firm: Nova Biomedical Corporation
Product: Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Glucose test strips reports no result message when tested
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Nova Biomedical, sent an "Urgent Field Safety Notice 01-13SS" dated March 18, 2013 and US customers notification by phone contact and to the International customers including a Faxback Form to be communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). The customers were instructed to INVALIDATE the Nova StatStrip Glucose Test Strip lots indicated in the list on all StatStrip meters within your institute; REPLACE all Nova StatStrip Glucose Test Strips from the indicated lots with replacement test strips provided by Nova; REMOVE all unused boxes of the Nova StatStrip Glucose Test Strip lots indicated from all locations within your institute; RETURN all unused boxes of the Nova StatStrip Glucose Test Strips lots indicated to Nova Biomedical U.K. or your local Nova distributor following the country specific instructions provided by your authorized Nova representative, and complete and return the Fax-Back Form via email or FAX to your Regional Service Manager at 781-8914806. On April 08, 2013, the firm expanded the recall notification to include one additional test strip lot #0313021309 which was shipped under two catalog numbers(Catalog # 42214 and Catalog# 51493). US Notification by phone contact with key customer contact facilitated by Senior Manger of Technical Support Services. International - Field Safety Notice and Faxback Form is being communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). Questions regarding this notice should be directed to the following Nova Biomedical EU Authorized Representative at: Nova Biomedical Innovation House, Aston Lane South Runcorn,WA7 3FY Telephone: + 44 1244 287087 Email: [email protected]. or US at (781) 894-0800.
Quantity in commerce: 2200 cases
Distribution: Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
Product codes and lots: Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1154-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1153-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-19
Z-1154-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-19

Product code CGA

K063821Class IINova Statstrip Glucose Hospital Meter SystemNova Biomedical Corp. / cleared 2007-01-24

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)