CLASS III ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report

RR Mechatronics Starrsed Control Level N ESR Control recalled

Mechatronics U is recalling RR Mechatronics Starrsed Control Level N ESR Control QRR049001- In-vitro diagnostic, distributed nationwide in the US. The recall was initiated on 14 Apr 2023 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022

Quantity recalled9306 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1694-2023
FDA event ID: 92276
Recalling firm: Mechatronics U, Warwick, RI
Classification: Class III
Status: Ongoing
Recall initiated: 14 Apr 2023
FDA classified: 7 Jun 2023
Reported: 14 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

14 Apr 2023	Recall initiated by company
7 Jun 2023	Classified by FDA	+54 days
14 Jun 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Is RR Mechatronics Starrsed Control Level N ESR Control QRR049001- In-vitro diagnostic recalled?

Yes. Mechatronics U recalled RR Mechatronics Starrsed Control Level N ESR Control QRR049001- In-vitro diagnostic on 14 Apr 2023. The recall is Class III and its status is Ongoing. Recall number Z-1694-2023.

Why was it recalled?

Which lots are affected?

UDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mechatronics U

All 2

Reported	Class	Recall	Company	Reason	Where
14 Jun 2023Device	CLASS III	RR Mechatronics Control Level A ESR Control4 recalled by Mechatronics U	Mechatronics U	Labeling Errors	Nationwide

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