# FDA recall Z-1694-2023

> **Mechatronics USA** · Class III · device recall initiated 2023-04-14.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of OH and the country of  Netherlands.

## Key facts

- **Recall number:** Z-1694-2023
- **Recalling firm:** Mechatronics USA
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-14
- **Report date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warwick, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2023

## Citation

> MORVS. FDA recall Z-1694-2023. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-1694-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*