RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to m
Summary
The FDA issued a Class III for RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro by Mechatronics USA. Reason: QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Contro.
Details
Source
Device Recall
External ID
Z-1694-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: (01)08719189137118(17)240222(10)QCAB6AN505 Lot Number/Exp Date: QCAB6AN505 24-02-2022
Quantity Affected: 9306 units
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.
Distribution
Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-14
Company
Warwick, RI
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mechatronics USA has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mechatronics USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mechatronics USA have FDA actions?
Mechatronics USA has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1694-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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