Roche Homocysteine Test Recalled for Calibration Failures and Quality Control Issues
Roche Diagnostics is recalling 82 units of Homocysteine tests due to calibration failures and quality control recovery issues on cobas c 701 and 702 modules.
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: The recall is classified as FDA Class II, and the hazard involves potential diagnostic errors due to calibration and quality control failures, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 82 units of the Roche Homocysteine in vitro test, catalog number 06542921190. The product is used for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. The recall is due to calibration failures and quality control recovery issues observed on cobas c 701 and 702 modules.
The affected lot number is 422313, with an expiration date of 07/31/2020. The product was distributed nationwide in the United States, specifically in the states of New Jersey, Hawaii, and Iowa. The agency has classified this recall as Class II.
Healthcare facilities and laboratories should stop using the affected product and contact Roche Diagnostics for further instructions. Consumers are not directly affected as this is an in vitro diagnostic test used in clinical settings.
The recalled product
- 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…
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 82
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 (1)
- Lot Number: 422313 Exp Date: 07/31/2020
Distribution
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