Beckman Coulter Recalls Opiate 300 Ng Reagent Due to Cross-Reactivity Issues
Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.
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 risk-of-harm product (medical diagnostic reagent) where injury has not yet been reported, but the hazard of false test results is significant.
Plain-English summary
Beckman Coulter Inc. is recalling 7,951 units of Opiate 300 Ng Reagent (OP 1 X 250), Catalogue No. 475024. This reagent is used with UniCel DxC 600/800 System(s) and SYNCHRON Systems for rapid screening of opiates and their metabolites in urine.
The recall was initiated because cross-reactivity testing may not meet the claims indicated in the Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
The affected products were distributed throughout the United States and to Puerto Rico. The specific lot numbers involved are M904130 and older, including M802097, M803045, M804024, M805123, M806080, M808069, M809218, M810293, M901044, M902086, and M903175. Healthcare facilities and laboratories should stop using these lots and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 7,951
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 (13)
- Catalog Number 475024
- UDI:15099590222970
- Lot Numbers: M904130 and older including M802097
- M803045
- M804024
- M805123
- M806080
- M808069
- M809218
- M810293
- M901044
- M902086
- and M903175. .
Distribution
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. 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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