Date Initiated by Firm |
April 14, 2023 |
Date Posted |
June 07, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1695-2023 |
Recall Event ID |
92276 |
Product Classification |
Device, automated sedimentation rate - Product Code GKB
|
Product |
RR 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) instruments and procedures. Product Code: A0026578 |
Code Information |
UDI:
(01)08719189137125(17)240222(10)QCAB6AAA28
Lot Number/Exp. Date:
QCAB6AAA28 24-02-2022
|
Recalling Firm/ Manufacturer |
Mechatronics USA 20 Altieri Way Unit 4 Warwick RI 02886-1761
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
10752 units |
Distribution |
Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
|
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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