Medical Device Homocysteine Test Assay Recalled for Calibration Defects
Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a functional defect (calibration and quality control issues) that can produce incorrect diagnostic results. No illnesses or injuries have been reported, but the defect poses a risk of patient harm through incorrect clinical decisions.
Plain-English summary
Roche Diagnostics Operations, Inc., is recalling 458 units of the cobas HCYS (Homocysteine Enzymatic Assay), Material Number REF 06542921190, for use on cobas c 701/702 laboratory analyzers. This assay is used to measure total L-homocysteine levels in patient blood samples.
The recall is due to abnormal calibration signals and control recovery issues affecting the assay. These defects can produce erroneous patient results with positive or negative bias, potentially leading to inaccurate test values.
The product was distributed to clinical laboratories in New Jersey, Texas, New York, Florida, Indiana, Oklahoma, South Carolina, and Iowa. The affected lot is Lot Number 747029 with expiration date September 30, 2024 (UDI/DI 04015630929979), affecting 458 units total.
Clinical laboratories should verify whether they have the affected lot and determine whether it was used for patient testing.
The recalled product
- Product
- cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 458
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 04015630929979
- Lot Number 747029
- exp. 30-SEPT-2024
Distribution
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