Access Vitamin B12 Reagent lot 439850 may produce inaccurate test results
Beckman Coulter's Access Vitamin B12 Reagent lot 439850 may produce falsely low or high results, potentially causing misdiagnosis or unnecessary repeat testing.
What this means for you
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: This Class II diagnostic reagent can produce inaccurate results that may lead to delayed or improper diagnosis. No patient illnesses or injuries have been reported, placing it in the 'risk-of-harm products where injury has not yet been reported' category per the severity rubric.
Plain-English summary
Beckman Coulter is recalling Access Vitamin B12 Reagent lot 439850 because the affected reagent may produce erroneous test results, showing values that are either falsely low or falsely high.
These inaccurate results can lead to delayed or improper diagnosis of vitamin B12 deficiency or levels of toxicity, and may cause patients to require repeat testing to obtain accurate results.
The recalled reagent was distributed internationally to 17 countries including Andorra, Bulgaria, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Maldives, Netherlands, Portugal, Romania, Spain, Switzerland, Turkey, and the United Kingdom. Approximately 10,000 units of this reagent lot were affected.
Laboratories currently using Vitamin B12 Reagent lot 439850 should immediately discontinue use and contact Beckman Coulter for replacement product or further information regarding this recall.
The recalled product
- Product
- Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- diagnostic-error
- inaccurate-results
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 (2)
- UDI-DI: 15099590224301
- Lot Number: 439850
Distribution
Distribution scope not specified by the agency.
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