Z-1694-2023Class III

RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control...

Name: Z-1694-2023 RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control...
Creator: Mechatronics USA
Published: 2023-04-14
License: https://open.fda.gov/license/

Mechatronics USA / initiated 2023-04-14 / Open, Classified / root cause: labeling and UDI

FDA source

Mechatronics USA began a recall of RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed... on 2023-04-14. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1694-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-04-14
Posted: 2023-06-07
Recalling firm: Mechatronics USA
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
Product code: GKB Device, Automated Sedimentation Rate
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Mechatronics issued Urgent Field Safety corrective action letter on 4/14/23 via email. Letter states reason for recall, health risk and action to take: Field Safety Field corrective action to be taken by the customer: 1. Confirm that you have received this information by returning enclosed acknowledgement form. 2. Please check your inventory for QRR049001-Starrsed Control Level N-Lot QCAB6AN505. 3. Please check your inventory for QRR049002-Starrsed Control Level A-Lot QCAB6AAA28. 4. Confirm the date and number of unused incorrectly labeled vials in your inventory. 5. Discard any unused incorrectly labelled vials in your inventory. 6. Please indicate the number of requested replacement vials. Please document the information on the enclosed Return Form and send to [email protected] Transmission of this notice We kindly ask you to inform those who need to be aware of this notification within your organization or any other organization to which the affected product(s) have been transferred. We need confirmation of the complete delivery of this lot. By completing the above-mentioned enclosed Return Form by yourself and affected customers.
Quantity in commerce: 9306 units
Distribution: Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
Product codes and lots: UDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1694-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1694-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-07
Z-1695-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-07

Product code GKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)