FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188.
- Recall number
- Z-1115-2008
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188.
- Status
- Terminated
- Initiated
- 2007-12-14
- Posted
- 2008-05-22
- Terminated
- 2008-09-15
- Reason
- Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Root cause
- Process control
- Action
- Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.
- Quantity
- 955 for all products.
- Distribution
- Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, Ukraine and West Indies.
- Lot, serial or model codes
- Lots 628302-025, 628302-346 and 704601-108.
- 510(k) numbers
- ["K941287"]
- PMA numbers
- not on file
- Product code
- CKA
- 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