FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
- Recall number
- Z-0223-2009
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
- Status
- Terminated
- Initiated
- 2008-09-10
- Posted
- 2008-10-31
- Terminated
- 2009-11-27
- Reason
- The inability of the product to maintain stated performance specifications through the stated shelf life.
- Root cause
- Process control
- Action
- Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.
- Quantity
- 63
- Distribution
- Nationwide, Canada, China, Romania and Trinidad.
- Lot, serial or model codes
- Lot 727501.
- 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