RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the

FDA device recall Z-1695-2023 · posted 2023-06-07 · Open, Classified

Recall details

Recalling firm

Mechatronics USA

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.

Action taken

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.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

GKB

Quantity affected

10752 units

Distribution

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

Date initiated

2023-04-14

Date posted

2023-06-07

Location

Warwick, RI