RR Mechatronics Starrsed Control Level N ESR Control 4 — Class III medical device recall Z-1694-2023
Ongoing recall by Mechatronics USA, reported 2023-06-14, distributed nationwide. QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will
| Recall number | Z-1694-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mechatronics USA, Warwick, RI, United States |
| Recall initiated | 2023-04-14 |
| Classified | 2023-06-07 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 9,306 units |
| UPC / GTIN / UDI-DI | 08719189137118 |
| Lot numbers | 24-02-2022, QCAB6AN505 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1694-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.