RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml… recallZ-1694-2023 · Mechatronics USA · initiated Apr 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mechatronics USA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1694-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 14, 2023
- Posted by the FDA
- Jun 7, 2023
- Recalling firm
- Mechatronics USA
- Quantity
- 9306 units
- Product code
- GKB
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
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
Code information (models, lots, serial numbers)
UDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Starrsed Control QRR049001RR Mechatronics Manufacturing B.V. · DEVICE, AUTOMATED SEDIMENTATION RATE1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92276).
- Z-1695-2023 · Open, ClassifiedRR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page