FDA Device recall Z-1695-2023
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starr…
- FDA Device
- Class III
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class III recall of RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starr… by Mechatronics Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1695-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-04-14 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mechatronics Usa |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | UDI: (01)08719189137125(17)240222(10)QCAB6AAA28 Lot Number/Exp. Date: QCAB6AAA28 24-02-2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1695-2023%22
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