FDA Medical Device Recalls (openFDA)
Hypoguard USA, Inc.: Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.
- Recall number
- Z-0275-04
- Recalling firm
- Hypoguard USA, Inc.
- Product
- Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.
- Status
- Terminated
- Initiated
- 2003-11-26
- Posted
- 2003-12-25
- Terminated
- 2005-11-21
- Reason
- When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
- Root cause
- Other
- Action
- The consignees were sent letters dated 11/26/03 which requested that the product be returned.
- Quantity
- 10-count bottles 6336; 50-count bottles 73,490; and 100-count bottles 221
- Distribution
- The product was distributed to consignees located nationwide in the United States.
- Lot, serial or model codes
- 01143A, 01023A, 01173A, 01293A, 01293B, 01303A 01303B, 02263A, 02263B, 02273A, 02273B, 02273C, 03113A, 11182A, 12282A, 12302A, 03113A, 03213A, 03263A, 03283A, 03283B, 04153A, 05293B, 04153B, 05293C, 04213A, 05293A, 04303A, 06063A, 05293D, and 05303A
- 510(k) numbers
- ["K020232"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 1832816
- Firm city
- Edina
- Firm state
- MN
- 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