RANDOX Total Bilirubin Reagent Recall Due to Elevated Patient Results
Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.
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: This FDA Class II medical device recall involves inaccurate test results, representing a risk of harm through diagnostic error. No illnesses, injuries, or deaths have been reported in the source text.
Plain-English summary
Randox Laboratories Ltd. is recalling RANDOX Total Bilirubin reagent units due to reports of elevated patient results. The recalled products include Catalog Nos. BR8377, BR9766, and BR4061, all batches.
The issue occurs when plasma (lithium heparin) samples are tested using the Total Bilirubin reagent with the Vanadate Oxidation Method. Reports indicate that patient results are elevated in these conditions.
The recalled product was distributed nationwide in Arkansas, Georgia, North Carolina, Tennessee, and Puerto Rico. Customers who use this reagent with lithium heparin plasma samples should contact Randox Laboratories Ltd. regarding the affected inventory.
The recalled product
- Product
- RANDOX Total Bilirubin.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- inaccurate-test-results
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)
- Catalog No. BR8377
- BR9766
- & BR4061
- GTIN: 05055273214772
- 05055273208337
- & 05055273214765
- All Batches.
Distribution
Distributed nationwide across the United States.
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