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.
What this means for you
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.
Related recalls
Same manufacturer · Roche Diagnostics Corporation
See all →- ModerateRoche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination
FDA (Devices) · 2019-07-24
- LowRoche cobas p 701 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- LowRoche cobas p 501 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- HighRoche Cobas infinity Software Recall for Missing Quality Control Alarms
FDA (Devices) · 2019-05-29
- SevereRoche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops
FDA (Devices) · 2019-05-08
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02