Z-2609-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 kits
Product Description
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Reason for Recall
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.
Distribution Pattern
US States: GA, OH, OR, PA, TX, VA
Code Information
UDI-DI: 05055273208986; Lot Number: 1308UE