ESR Diagnostic Control Vials Recalled for Incorrect Lot Labeling
Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.
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: FDA Class III recall involving a labeling error with no reported illnesses or injuries. The hazard is operational rather than safety-related—mislabeling causes false instrument calibration flags—meeting the rubric criterion for minor labeling errors.
Plain-English summary
Mechatronics USA has recalled approximately 10,752 units of RR Mechatronics Control Level A ESR Control (actual Lot QCAB6AN505) that were incorrectly labeled as QRR049002 Lot QCAB6AAA28. This product is an in-vitro diagnostic quality control material used to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments.
Due to the incorrect labeling, vials bearing the wrong lot number will not properly calibrate the ESR instrument. When used in testing, the instrument will incorrectly flag results as out of range, even though the quality control material itself is not defective.
The affected vials were distributed worldwide, including to Ohio and the Netherlands. Users who have received vials labeled as QRR049002 Lot QCAB6AAA28 should verify the actual contents and contact Mechatronics USA if they believe they have affected product. Facilities should review their recent ESR instrument testing and quality control procedures if out-of-range flags were recently observed with this control material.
The recalled product
- Product
- RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578
- Manufacturer
- Mechatronics USA
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
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