Pointe Scientific, Inc. Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog number HG420-R1. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog number HG420-R1.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
Lots 511901, exp. 4/07 and 525101, exp. 9/07.
Products Sold
Lots 511901, exp. 4/07 and 525101, exp. 9/07.
Pointe Scientific, Inc. is recalling Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose due to Product does not meet performance specifications through its labeled expiration period.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product does not meet performance specifications through its labeled expiration period.
Recommended Action
Per FDA guidance
Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.
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