Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
This recall has been terminated (originally issued May 22, 2008).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- December 14, 2007
- Posted
- May 22, 2008
- Terminated
- September 15, 2008
- Recall Number
- Z-1111-2008
- Quantity
- 955 for all products.
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
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 / Code Info
Lots 628302-023, 628302-024, 628302-025, 628302-067, 628302-068, 704601-068, 704601-107, 704601-108, 704601-109, 704601-134 and 704601-166.
Root Cause
Process control
Action Taken
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.