Z-2165-2017Class II

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro...

Name: Z-2165-2017 Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro...
Creator: Medtest Holdings, Inc.
Published: 2011-07-08
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2011-07-08 / Terminated / root cause: manufacturing process

FDA source

Medtest Holdings, Inc. began a recall of Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate... on 2011-07-08. FDA classified it as Class II and gives the reason as "Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met". 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-2165-2017
Classification: Class II
Status: Terminated
Initiated: 2011-07-08
Posted: 2017-05-26
Terminated: 2017-06-02
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Product code: CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Reason for recall: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Pointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website.
Quantity in commerce: 716.146L total
Distribution: Nationwide
Product codes and lots: L7572 all configurations

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2165-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2165-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-26

Product code CFJ

K973589Class IILiquid Ldh-L Reagent SetPointe Scientific, Inc., / cleared 1997-10-08

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)