Z-2768-2015Class II

MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm...

Name: Z-2768-2015 MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm...
Creator: MedtestDx, Inc.
Published: 2015-05-15
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2015-05-15 / Terminated / root cause: manufacturing process

FDA source

MedtestDx, Inc. began a recall of MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control... on 2015-05-15. FDA classified it as Class II and gives the reason as "Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63...". 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-2768-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Posted: 2015-09-15
Terminated: 2016-05-23
Recalling firm: Horiba Instruments Incorporated
Product: MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 5/15/2015, MedTest DX Field Correction Notice notifications were sent to the affected customers via electronic mail and US mail. 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. Any questions concerning the corrective action may be directed to MedTest Technical Service Department at 1-800-757-5313.
Quantity in commerce: 79 kits
Distribution: US Nationwide Distribution.
Product codes and lots: Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2768-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2768-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-15

Product code JJY

K942458Class IPrecision-Multi-Sera - Human - Normal and ElevatedRandox Laboratories, Ltd. / cleared 1995-03-13

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)