Z-1695-2023 Class III Ongoing
FDA device recall Z-1695-2023 was initiated by Mechatronics USA on Apr 14, 2023 and is designated Class III. 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… The recall status is ongoing. Affected quantity: 10752 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 14, 2023
- Initiation Date
- Apr 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10752 units
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.
Distribution pattern
Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
Code information
UDI: (01)08719189137125(17)240222(10)QCAB6AAA28 Lot Number/Exp. Date: QCAB6AAA28 24-02-2022
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1695-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026