Z-2390-2018Class II

Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160

Name: Z-2390-2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160
Creator: Roche Diagnostics Corporation
Published: 2018-04-27
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-04-27 / Terminated

FDA source

Roche Diagnostics Corporation began a recall of Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of... on 2018-04-27. FDA classified it as Class II and gives the reason as "The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2390-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-27
Posted: 2018-07-08
Terminated: 2020-05-11
Recalling firm: Roche Diagnostics GmbH
Product: Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.
Product code: MRG System, Test, Vitamin D
Reason for recall: The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
FDA root cause: Under Investigation by firm
Action: On April 27, 2018, the firm issued an Urgent Medical Device Correction letter to all affected customers. The letter advised customers in the following workaround to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay. The firm stated these steps are to be carried out temporarily until further information is provided: 1. Perform a thorough inspection of your pre-analytical handling to ensure a correct assay performance of Elecsys Vitamin D total II and to comply with the individual specifications of the primary tube manufacturers for all tubes in use (centrifugation conditions are particularly important as well as the elimination of foam/bubbles from the surface of the sample). 2. If the issue persists, switch from plasma to serum. 3. If you still encounter the issue for plasma or serum, re-centrifuge the sample in a secondary tube for 10 minutes at 2000 x g prior to measurement with the Elecsys Vitamin D total II assay. If you are still experiencing issues after completing the steps above, discontinue the use of the Elecsys Vitamin D Total II assay. Contact the Roche Support Network Customer Support Center at 1-800-428-2336. For the MODULAR ANALYTICS E 170 module, cobas e 411 analyzer, and cobas e 601 and 602 analyzers, the availability of the Elecsys Vitamin D Assay (catalog number 06506780160) has been extended and may be used as an alternate method until this issue is resolved. Customers were asked to do the following: " Follow the workaround outlined in this Urgent Medical Device Correction (UMDC) to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay until further information is provided. " If none of the workaround actions listed on the previous page successfully resolve the issue, please discontinue use of the Elecsys Vitamin D total II assay and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " For all analyzers except the cobas e 801 module, the V
Quantity in commerce: 3591 units
Distribution: US Nationwide distribution.
Product codes and lots: No specific lot codes. This issue affects users of the MODULAR ANALYTICS E 170 module, cobas e 411 analyzer, and cobas e 601 and 602 modules

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2390-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2389-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-08
Z-2390-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-08

Product code MRG

K162840Class IIElecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5Roche Diagnostics / cleared 2017-02-08

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)