Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples
Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.
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: The recall involves a medical device with a significant analytical error (positive bias) that could lead to incorrect clinical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Randox Laboratories, Ltd. is recalling 143 kits of the AM1054 Randox Ammonia (NH3), Enzymatic UV Method. This product is used for the quantitative in vitro determination of Ammonia in plasma. The recall is due to a positive bias of up to 140 µmol/l being observed on patient samples.
The affected product is identified by Catalogue Number AM1054, GTIN 05055273200263, and Lot # 512103 (batch 512103). The product was distributed in the United States to the states of Virginia, Utah, and West Virginia, as well as to Canada.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
- Manufacturer
- RANDOX LABORATORIES, LTD.
- Affected units
- 143
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)
- Catalogue Number: AM1054 GTIN: 05055273200263 Lot #: 512103 batch 512103
Distribution
Part of a larger recall action
This product is one of 2 recalled by RANDOX LABORATORIES, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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