FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L.
- Recall number
- Z-1331-06
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L.
- Status
- Terminated
- Initiated
- 2006-06-07
- Posted
- 2006-08-03
- Terminated
- 2007-11-19
- Reason
- Product does not meet performance specifications through its labeled expiration period.
- Root cause
- Other
- Action
- Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.
- Quantity
- 61 bottles
- Distribution
- Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.
- Lot, serial or model codes
- Lots 431704 and 511901.
- 510(k) numbers
- ["K002199"]
- PMA numbers
- not on file
- Product code
- CFR
- Firm FEI
- 1827821
- Firm city
- Canton
- Firm state
- MI
- 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