FDA Enforcement
Class II
Ongoing
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Recall: Z-2609-2023
·
Reported September 27, 2023
Enforcement
- Recall Number
- Z-2609-2023
- Event ID
- 92912
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 27, 2023
- Initiation Date
- August 3, 2023
- Classification Date
- September 19, 2023
- Address
- 55 Diamond Road, Crumlin (North), N/A, Ireland
Description
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Reason
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Code Info
UDI-DI: 05055273208986; Lot Number: 1308UE
Distribution
US States: GA, OH, OR, PA, TX, VA
Quantity
66 kits