Beckman Coulter Recalls Synchron Opiate 2000 ng Reagent Due to Cross-Reactivity
Beckman Coulter is recalling Synchron Opiate 2000 ng Reagent because cross-reactivity testing may not meet instructions for use, 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential false positive or negative test results due to cross-reactivity, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens, fitting the Moderate criteria for labeling/quality errors without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling 1,610 units of Synchron Systems Opiate 2000 ng Reagent (catalogue no. 475006). This reagent is used with UniCel DxC 600/800 Systems and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators to provide a rapid screening procedure for the presence of opiates 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 lot numbers include M904147 and older, specifically M810039, M901087, and M904147.
The product was distributed throughout the United States and to Puerto Rico. Specific states listed in the distribution pattern include CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, OH, AZ, LA, NY, PA, KY, WV, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, and WI. Users of the product should contact Beckman Coulter for further instructions on handling the recalled reagent.
The recalled product
- Product
- Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 1,610
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 (6)
- Catalog Number 475006
- UDI: 15099590222031
- Lot Numbers: M904147 and older including M810039
- M901087 and M904147) and 4 lots OP2 (M805122
- M810039
- and M901087. .
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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