Device 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
Z-1694-2023
Product summary
- Firm
- Mechatronics USA
- Event
- Event 92276
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 9306 units
- Official record key
device-enforcement:Z-1694-2023
Official wording
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.
Code information: UDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
Derived failure modes
-
Unknown
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.