Roche Recalls PreciControl Varia 3 Due to Typographical Error
Roche Diagnostics is recalling 1,603 units of Elecsys PreciControl Varia 3 because the e-barcode and value sheet contain a typographical error for PTH target 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a typographical error in documentation (e-barcode and value sheet) rather than a physical defect or contamination. This aligns with the rubric for minor labeling or documentation issues.
Plain-English summary
Roche Diagnostics Corporation is recalling 1,603 units of Elecsys PreciControl Varia 3. The recall is limited to Lot Number 189285, which has an expiration date of 10/31/2017 and Part Number 05618860160. The product was distributed nationwide.
The recall was initiated because the e-barcode and value sheet for the PreciControl Varia contain a typographical error regarding the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays. This error could potentially affect the accuracy of quality control results for these specific tests.
Healthcare facilities and laboratories that have received this product should stop using the affected units and contact Roche Diagnostics Corporation for further instructions or a replacement.
The recalled product
- Product
- Elecsys PreciControl Varia 3
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 1,603
Distribution
Distributed nationwide across the United States.
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