CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
Roche Homocysteine-In vitro test recalled
Roche Diagnostics Operations is recalling Roche Homocysteine-In vitro test for the quantitative determination of total, distributed nationwide in the US. The recall was initiated on 4 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0679-2020
- FDA event ID
- 84018
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Oct 2019
- FDA classified
- 13 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Oct 2019 | Recall initiated by company | |
| 13 Dec 2019 | Classified by FDA | +70 days |
| 25 Dec 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of NJ, HI, IA.
Questions about this recall
Why was it recalled?
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Which lots are affected?
Lot Number: 422313 Exp Date: 07/31/2020
Where was it sold?
US Nationwide distribution in the states of NJ, HI, IA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roche Diagnostics Operations
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | cobas pro integrated solutions recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Potency & Assay | Nationwide |
| Device | CLASS II | The Elecsys Anti-TSHR immunoassay is a three-step recalled | Roche Diagnostics Operations | Particulate Matter | Nationwide |
| Device | CLASS II | cobas HCYS, Homocysteine Enzymatic Assay, Material Number recalled | Roche Diagnostics Operations | Potency & Assay | 8 states |
| Device | CLASS II | Creatine Kinase (CK) used on cobas c 311/501/502 recalled | Roche Diagnostics Operations | Potency & Assay | Nationwide |
| Device | CLASS II | Tina-quant D-Dimer Test System recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Potency & Assay | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |