Medical Device Calibration Serums Recalled Due to Instructional Transcription Errors
Randox Laboratories has recalled multiple calibration serum products due to transcription errors in the Instructions for Use, which contain incorrect target values for several analytes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm medical device recall where instruction documentation errors could impair laboratory calibration accuracy. FDA Class II classification with documentation/instruction errors rather than contamination or device defect, and no illnesses or injuries reported.
Plain-English summary
Randox Laboratories Ltd. is recalling calibration serum products due to transcription errors on the Instructions for Use. The affected products are Calibration Serum Level 3 (CAL2351, lots 1260UE, 1262UE, 1315UE), Human Assayed Multi-Sera Level 2 (HN1530), and Human Assayed Multi-Sera Level 3 (HE 1532). These products have been distributed nationwide across the United States.
Calibration serums are control samples used to verify the accuracy of laboratory testing equipment. The errors involve incorrect target values transcribed on the instructions: incorrect Bilirubin and Triglycerides values on CAL2351, incorrect TBIC target value on HN1530, and incorrect Lipase target value on HE 1532. These target values are essential for correct calibration of diagnostic laboratory equipment.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: 05055273200966
- lot1260UE
- exp. 28 Nov 2024
- lot 1262UE
- exp. 28 Jan 2025
- and lot 1315UE
- exp. 28 May 2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27