Z-1622-2015Class II

Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA...

Name: Z-1622-2015 Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA...
Creator: Roche Diagnostics Operations, Inc.
Published: 2015-03-23
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2015-03-23 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test... on 2015-03-23. FDA classified it as Class II and gives the reason as "Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low...". 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-1622-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Posted: 2015-05-15
Terminated: 2016-01-19
Recalling firm: Roche Diagnostics GmbH
Product: Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Roche Diagnostics sent URGENT MEDICAL DEVICE CORRECTION notifications dated 3/23/2015 to affected direct accounts via UPS. 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. 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.
Quantity in commerce: 2558 units
Distribution: Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.
Product codes and lots: 05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1622-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1622-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-15

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)