FDAFDA · Food and drugs·Recall number Z-0751-2024
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Published January 24, 2024 · Recall initiated: November 13, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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