Mechatronics USA: Medical Device Recall in 2023 - (Recall #: Z-1694-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: April 14, 2023

Date Posted: June 14, 2023

Recall Number: Z-1694-2023

Event ID: 92276

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.

Status: Ongoing

Product Quantity: 9306 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated