Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
Lots 628302-005, 628302-059, 628302-085, 628302-086, 628302-087, 704601-087, 704601-130, 704601-131, 704601-134 and 704601-191.
Products Sold
Lots 628302-005, 628302-059, 628302-085, 628302-086, 628302-087, 704601-087, 704601-130, 704601-131, 704601-134 and 704601-191.
Pointe Scientific, Inc. is recalling Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminot due to Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026