Pointe Scientific, Inc. Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
Lot 522202, exp. 7/06.
Products Sold
Lot 522202, exp. 7/06.
Pointe Scientific, Inc. is recalling Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufact 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