ESR Diagnostic Quality Control Material Incorrectly Labeled as Different Level
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
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: This is a Class III FDA recall involving a labeling error on diagnostic quality control material. While no illnesses or injuries have been reported, the mislabeling causes measurement errors and false out-of-range flags that disrupt quality control procedures, meeting the threshold for Moderate severity.
Plain-English summary
Mechatronics USA is recalling 9,306 units of RR Mechatronics Starrsed Control Level N ESR Control, an in-vitro diagnostic quality control material used to monitor the precision of Erythrocyte Sedimentation Rate (ESR) instruments. Lot QCAB6AN505 was incorrectly labeled as QRR049002 Lot QCAB6AAA28 instead of the correct product designation.
When used with Starrsed ESR instruments, the mislabeled vials will upload the calibration range for Control Level A instead of Control Level N. This causes the instrument to flag results as out of range, disrupting the quality control procedure. The error would be detected by the instrument during use when it identifies that the control material does not match the expected range.
Affected units were distributed worldwide, including in the United States (Ohio) and the Netherlands. The recalled lot is QCAB6AN505 with expiration date February 22, 2024.
If you have received this lot, remove it from service immediately and do not use it for ESR instrument calibration or quality control. Contact Mechatronics USA for a corrected replacement. Laboratories and healthcare facilities using Starrsed ESR instruments should verify their inventory and ensure this lot is not in active use.
The recalled product
- Product
- RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577
- Manufacturer
- Mechatronics USA
- Affected units
- 9,306
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.
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