FDA Medical Device Recalls (openFDA)
Mechatronics USA: 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
- Recall number
- Z-1694-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-04-14
- Posted
- 2023-06-07
- Terminated
- not on file
- Reason
- 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
- 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 sales@rrmechatronics.com 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
- 9306 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
- Lot, serial or model codes
- UDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKB
- Firm FEI
- 3004016971
- Firm city
- Warwick
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28