Device recall: RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to m
FDA enforcement event 92276 is a device recall by Mechatronics USA of Warwick, RI, initiated 14 Apr 2023 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 2% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Mechatronics USA.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mechatronics USA, Warwick, RI.
Reason for recall
"QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range."
Distribution
"Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1694-2023 | 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 | 9306 units | Class III | Ongoing | 14 Jun 2023 |
| Z-1695-2023 | 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 | 10752 units | Class III | Ongoing | 14 Jun 2023 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.