Pointe Scientific, Inc. Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
Lot 727501.
Products Sold
Lot 727501.
Pointe Scientific, Inc. is recalling Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry) due to The inability of the product to maintain stated performance specifications through the stated shelf life.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The inability of the product to maintain stated performance specifications through the stated shelf life.
Recommended Action
Per FDA guidance
Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.
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