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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
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