Z-2116-2017Class III

Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP...

Name: Z-2116-2017 Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP...
Creator: Medtest Holdings, Inc.
Published: 2012-02-15
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2012-02-15 / Terminated / root cause: labeling and UDI

FDA source

Medtest Holdings, Inc. began a recall of Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry... on 2012-02-15. FDA classified it as Class III and gives the reason as "A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2116-2017
Classification: Class III
Status: Terminated
Initiated: 2012-02-15
Posted: 2017-05-18
Terminated: 2017-06-02
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Product code: CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Reason for recall: A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Technical Bulletin Notification letter was sent 02/15/12 by email to all customers and distributors. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-757-5313.
Quantity in commerce: 119.168L across All lots
Distribution: US Nationwide Distribution
Product codes and lots: Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2116-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2116-2017	Class III	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-18

Product code CIT

K941132Class IILiquid Ast (Sgot)reagent SetPointe Scientific, Inc., / cleared 1994-05-02

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)