FDA Medical Device Recalls (openFDA)
Nova Biomedical Corporation: Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
- Recall number
- Z-0650-2014
- Recalling firm
- Nova Biomedical Corporation
- Product
- Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
- Status
- Terminated
- Initiated
- 2013-10-10
- Posted
- 2014-01-09
- Terminated
- 2014-03-24
- Reason
- Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
- Root cause
- Component design/selection
- Action
- On November 18, 2013, an URGENT Field Correction Letter was sent to all StatStrip Glucose Hospital meter, StatStrip Lactate Hospital Meter and StatSensor Creatinine Hospital Meter customers via email to the Point of Care Coordinator to alert users that lithium batteries that are utilized beyond their intended useful life may swell and/or crack posing a potential safety hazard. In some cases, the swelling may potentially cause the battery door on the meter to dislodge and render the meter inoperable.
- Quantity
- est. 200,000
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K060345","K063821","K070068"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 1219029
- Firm city
- Waltham
- Firm state
- MA
- 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