Recall Z-1694-2023— Mechatronics USA
Class III · Ongoing
Class III FDA medical device recall by Mechatronics USA, initiated 2023-04-14. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Mechatronics USA
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2023-04-14
- Firm location
- Warwick, RI, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.