Z-0679-2020Class II

Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum...

Name: Z-0679-2020 Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum...
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-10-04
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-10-04 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog... on 2019-10-04. FDA classified it as Class II and gives the reason as "Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0679-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-04
Posted: 2019-12-13
Terminated: 2020-10-09
Recalling firm: Roche Diagnostics GmbH
Product: Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Root cause tag: design
FDA root cause: Device Design
Action: The Urgent Medical Device Correction (UMDC) was sent via Roche issued Urgent Medical Device notification via FedEx (signature required) to the consignee list on 10/04/2019. The letter states issue, health risk nd action to take: Discontinue use and discard the remaining affected product in inventory according to local waste guidelines. Because a replacement lot is currently not available, Roche will issue credit for Homocysteine cobas c packs, lot number 422313, remaining in your inventory. If customers have another validated system (i.e. cobas c501/502) in their lab and wish to set up the Roche Homocysteine assay on one of these modules (different catalog number than that subject to this recall), they will be instructed to contact a Roche Field Specialist for support. " A reimbursement for send out testing to an accredited laboratory will also be provided for those customers without another Roche system available. 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 The UMDC will also be posted to the diagnostics.roche.com website.
Quantity in commerce: 82 units (US)
Distribution: US Nationwide distribution in the states of NJ, HI, IA.
Product codes and lots: Lot Number: 422313 Exp Date: 07/31/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0679-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0679-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-13

Product code LPS

K113793Class IIHomocysteine TestRoche / cleared 2012-06-05

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)