Z-1358-2008

Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500...

Name: Z-1358-2008 Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500...
Creator: Pointe Scientific, Inc.
Published: 2008-02-07
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2008-02-07 / Terminated

FDA source

Pointe Scientific, Inc. began a recall of Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120... on 2008-02-07. The reason FDA records is "May be contaminated with microorganisms". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1358-2008
Status: Terminated
Initiated: 2008-02-07
Posted: 2008-03-27
Terminated: 2009-06-12
Recalling firm: Horiba Instruments Incorporated
Product: Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120 mL , 2 L and 500 mL containers, Sold by Pointe Scientific.
Product code: CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Reason for recall: May be contaminated with microorganisms.
FDA root cause: Other
Action: Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, 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 consignees were notified via email.
Quantity in commerce: 78
Distribution: Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
Product codes and lots: All Lots beginning with 727801; exp. 4/09.

Product code CJE

K973588Class IILiquid Alkaline Phoshatase Reagent SetPointe Scientific, Inc., / cleared 1997-10-22

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)