Pointe Scientific, Inc. Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported and marketed in India by Ranbaxy Laboratories Ltd., New Delhi; Catalog # A7504-150-S. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported and marketed in India by Ranbaxy Laboratories Ltd., New Delhi; Catalog # A7504-150-S.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
Lot 507401.
Products Sold
Lot 507401.
Pointe Scientific, Inc. is recalling Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported and marke due to Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Recommended Action
Per FDA guidance
Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
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