Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples
Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with significant potential for adverse health consequences such as diagnostic errors.
Plain-English summary
Randox Laboratories, Ltd. is recalling 143 kits of the AM1015 Randox Ammonia (NH3), Enzymatic UV Method reagent. 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 AM1015, GTIN 05022273200256, and Lot Number 517541. The recall is classified as Class II by the FDA. The affected units were distributed in the United States to Virginia, Utah, and West Virginia, as well as to Canada.
Healthcare facilities and laboratories that have received this product should stop using the affected lots and contact Randox Laboratories for further instructions. No specific consumer action is required for the general public, as this is a professional in vitro diagnostic product.
The recalled product
- Product
- AM1015 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: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541
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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