Z-1041-2010

Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton...

Name: Z-1041-2010 Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton...
Creator: Pointe Scientific, Inc.
Published: 2009-11-10
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-11-10 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium... on 2009-11-10. The reason FDA records is "Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated". 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-1041-2010
Status: Terminated
Initiated: 2009-11-10
Posted: 2010-03-10
Terminated: 2010-12-10
Recalling firm: Horiba Instruments Incorporated
Product: Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC902-SAM-911. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
Product code: CIC Cresolphthalein Complexone, Calcium
Reason for recall: Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Quantity in commerce: 44 sets
Distribution: Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
Product codes and lots: All lots containing 813401 as part of the lot number.

Product code CIC

K822469Class IIPsi Calcium ReagentPointe Scientific, Inc., / cleared 1982-09-14

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)