Z-2173-2017Class II

Elecsys PreciControl Varia 3

Name: Z-2173-2017 Elecsys PreciControl Varia 3
Creator: Roche Diagnostics Corporation
Published: 2017-04-10
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2017-04-10 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corporation began a recall of Elecsys PreciControl Varia 3 on 2017-04-10. FDA classified it as Class II and gives the reason as "e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays". 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-2173-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Posted: 2017-05-31
Terminated: 2017-08-04
Recalling firm: Roche Diagnostics GmbH
Product: Elecsys PreciControl Varia 3
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 4/10/2017, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected consignees via courier. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in commerce: 1603
Distribution: Nationwide
Product codes and lots: Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2173-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2173-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-31

Product code JJY

K111506Class IElecsys Precicontrol Varia 3Roche Diagnostics / cleared 2011-07-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)