FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate amoinotransferase in human serum
- Recall number
- Z-0171-2009
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate amoinotransferase in human serum
- Status
- Terminated
- Initiated
- 2008-08-25
- Posted
- 2008-10-22
- Terminated
- 2009-11-27
- Reason
- The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
- Root cause
- Material/Component Contamination
- Action
- Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.
- Quantity
- 109 kits
- Distribution
- Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.
- Lot, serial or model codes
- A7561-150 lots 728504-046 and 728504-094. A7561-450 lot 728504-063. Exp. 4/09.
- 510(k) numbers
- ["K941132"]
- PMA numbers
- not on file
- Product code
- CIT
- 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