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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: 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
- Affected units
- 10,752
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mechatronics USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Mechatronics USA
See all →- ModerateESR Diagnostic Quality Control Material Incorrectly Labeled as Different Level
FDA (Devices) · 2023-06-14
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