Medical Device Calibration Standard Assigned Incorrectly in NEFA CAL Kit
Randox Laboratories recalls NEFA CAL IVD calibration standard kits (Batch 544642) due to incorrectly assigned calibration values that could cause measurement errors up to 8% in quality control and patient test results.
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: FDA Class II medical device—a risk-of-harm product where injury has not yet been reported. The incorrectly assigned calibration standard would cause systematic measurement errors up to 8% in clinical laboratory results, potentially affecting diagnostic accuracy and patient care decisions.
Plain-English summary
Randox Laboratories Ltd. is recalling 71 kits of NEFA CAL (Non-Esterified Fatty Acids) IVD Standard for measurement, Catalog Number FA115, Batch Number 544642, with expiration date November 28, 2022.
The calibration standard value has been assigned incorrectly. When used to calibrate analytical equipment, this incorrect standard will cause a positive shift of up to 8% in both quality control measurements and patient sample results.
The affected kits were distributed nationwide in Arkansas, California, Connecticut, New York, Ohio, Pennsylvania, Tennessee, and Texas.
No reported illnesses or adverse events related to this product have been identified. Laboratories using this batch should discontinue use and contact Randox Laboratories for replacement kits or additional guidance.
The recalled product
- Product
- NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- calibration-error
- measurement-error
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 (1)
- Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Distribution
Distributed nationwide across the United States.
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