Z-2063-2016Class II

Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in...

Name: Z-2063-2016 Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in...
Creator: Medtest Holdings, Inc.
Published: 2015-04-03
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2015-04-03 / Terminated / root cause: manufacturing process

FDA source

Medtest Holdings, Inc. began a recall of Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one... on 2015-04-03. FDA classified it as Class II and gives the reason as "Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay...". 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-2063-2016
Classification: Class II
Status: Terminated
Initiated: 2015-04-03
Posted: 2016-06-28
Terminated: 2016-07-05
Recalling firm: Horiba Instruments Incorporated
Product: Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: On 4/3/2015, Urgent Field Safety Notice notifications were sent to the affected customers via email with instructions for identifying and destroying the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Quantity in commerce: 13
Distribution: MI, MN, NJ, IL, NY. US Only.
Product codes and lots: Model: H7575-57 Lot: 416703 Expiration date: 2016-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2063-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2063-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28

Product code LPS

K083222Class IIAxis-Shield Liquid Stable (Ls) 2-Part Homocysteine Reagent, Model Fhrk100Axis-Shield Diagnostics, Ltd. / cleared 2009-07-31

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)