CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report
cobas HCYS, Homocysteine Enzymatic Assay, Material Number recalled
Roche Diagnostics Operations is recalling cobas HCYS, Homocysteine Enzymatic Assay, Material Number, distributed in 8 states. The recall was initiated on 17 Oct 2024 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-0489-2025
- FDA event ID
- 95609
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Oct 2024
- FDA classified
- 19 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Oct 2024 | Recall initiated by company | |
| 19 Nov 2024 | Classified by FDA | +33 days |
| 27 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Where it was distributed
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
FloridaIowaIndianaNew JerseyNew YorkOklahomaSouth CarolinaTexas
Questions about this recall
Why was it recalled?
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Which lots are affected?
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Where was it sold?
US: NJ, TX, NY, FL, IN, TX, OK, SC, 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.
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