Z-1397-06

Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers...

Name: Z-1397-06 Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers...
Creator: Pointe Scientific, Inc.
Published: 2006-06-09
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2006-06-09 / Terminated

FDA source

Pointe Scientific, Inc. began a recall of Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos... on 2006-06-09. The reason FDA records is "The reagent may be contaminated with microorganisms". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1397-06
Status: Terminated
Initiated: 2006-06-09
Posted: 2006-08-10
Terminated: 2007-11-19
Recalling firm: Horiba Instruments Incorporated
Product: Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos. 7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90, 8-A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. In vitro diagnostic.
Product code: CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Reason for recall: The reagent may be contaminated with microorganisms.
FDA root cause: Other
Action: Consignees were notified via recall letter dated 6/9/06 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 consignees were notified via email.
Quantity in commerce: 890 L total, all products
Distribution: Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela.
Product codes and lots: Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07).

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)