Z-0223-2009

Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)

Name: Z-0223-2009 Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Creator: Pointe Scientific, Inc.
Published: 2008-09-10
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2008-09-10 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry) on 2008-09-10. The reason FDA records is "The inability of the product to maintain stated performance specifications through the stated shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0223-2009
Status: Terminated
Initiated: 2008-09-10
Posted: 2008-10-31
Terminated: 2009-11-27
Recalling firm: Horiba Instruments Incorporated
Product: Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Product code: CFR Hexokinase, Glucose
Reason for recall: The inability of the product to maintain stated performance specifications through the stated shelf life.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 63
Distribution: Nationwide, Canada, China, Romania and Trinidad.
Product codes and lots: Lot 727501.

Product code CFR

K002199Class IIModification to Liquid Glucose (Hexokinase) Reagent SetPointe Scientific, Inc., / cleared 2000-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)