FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L .
- Recall number
- Z-1458-06
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L .
- Status
- Terminated
- Initiated
- 2006-06-12
- Posted
- 2006-08-30
- Terminated
- 2007-11-19
- Reason
- Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Root cause
- Other
- Action
- Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
- Quantity
- To be determined
- Distribution
- Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela.
- Lot, serial or model codes
- Lots 523002, exp. 2/07, and 531801, exp. 2/07.
- 510(k) numbers
- ["K992002"]
- PMA numbers
- not on file
- Product code
- CCH
- 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