Beckman Coulter Recalls Barbiturates Reagent Due to Potential Test Inaccuracy
Beckman Coulter is recalling SYNCHRON Systems Barbiturates Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative 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 is classified as FDA Class II and involves a risk-of-harm product (medical diagnostic) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling 10,145 units of SYNCHRON Systems Barbiturates Reagent (Catalog No. 475012). The product is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL. The recall covers specific lot numbers including M903174, M902167, M801045, M811093, M809230, M807116, M806172, M805116, M804028, M803040, M802093, and older lots.
The firm identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet. The presence of certain compounds in urine may result in false positive or false negative results. This recall is classified as Class II by the FDA.
The affected product was distributed worldwide, including nationwide in the US and to multiple countries. Users should stop using the affected reagent and contact Beckman Coulter Inc. for further instructions.
The recalled product
- Product
- SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 10,145
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 (14)
- SYNCRHON Systems BARB 1 X 250)
- Catalog No. 475012
- UDI: 15099590223007
- Lot Numbers M903174
- M902167
- M801045
- M811093
- M809230
- M807116
- M806172
- M805116
- M804028
- M803040
- M802093 and older.
Distribution
Distributed nationwide across the United States.
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