FDA Medical Device Recalls (openFDA)
Nova Biomedical Corporation: 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.
- Recall number
- Z-1783-2010
- 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.
- Status
- Terminated
- Initiated
- 2010-02-12
- Posted
- 2010-06-10
- Terminated
- 2011-07-22
- Reason
- Glucose strips report low glucose results
- 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
- 392 Cases (1800 strips each)
- Distribution
- Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.
- Lot, serial or model codes
- Lot Number: 0309019249, Expiration Date: 1/31/2011.
- 510(k) numbers
- ["K060345","K063821","K070960"]
- 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