Pointe Scientific, Inc. Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
Lots 523002, exp. 2/07, and 531801, exp. 2/07.
Products Sold
Lots 523002, exp. 2/07, and 531801, exp. 2/07.
Pointe Scientific, Inc. is recalling Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH94 due to Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Recommended Action
Per FDA guidance
Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
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