RR Mechatronics Control Level A ESR Control4.6 ml recall
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed…
Why was RR Mechatronics Control Level A ESR Control4.6 ml 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)08719189137125(17)240222(10)QCAB6AAA28 Lot Number/Exp. Date: QCAB6AAA28 24-02-2022
- Product
- RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed…
- Recalling firm
- Mechatronics USA
- Quantity
- 10752 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.
- Recall date
- June 14, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)