Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml Recalled by Mechatronics USA Due to QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot...

Date: April 14, 2023
Company: Mechatronics USA
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mechatronics USA directly.

Affected Products

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

Quantity: 9306 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mechatronics USA

Mechatronics USA has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report