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
Reported: June 14, 2023 Initiated: April 14, 2023 #Z-1694-2023
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.
Details
- Recalling Firm
- Mechatronics USA
- Units Affected
- 9306 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
- Location
- Warwick, RI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mechatronics USA. Units affected: 9306 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Low. Recall number: Z-1694-2023.
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