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
Reported: June 14, 2023 Initiated: April 14, 2023 #Z-1695-2023
Product Description
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
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
- 10752 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 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. Recalled by Mechatronics USA. Units affected: 10752 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-1695-2023.
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