Z-0751-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- November 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Reason for Recall
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025