Access Vitamin B12 reagent lot can give erroneously low or high results
Access Vitamin B12 Reagent lot 439850 is being recalled after complaints of erroneous results, which may lead to a delayed or improper diagnosis or repeat testing. 10,000 units are affected.
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: Risk-of-harm product: the manufacturer states the reagent may give erroneous results leading to improper diagnosis, with no patient harm reported in the source.
Plain-English summary
Access Vitamin B12 Reagent, catalog number 33000, lot number 439850, UDI-DI 15099590224301, is being recalled. The action covers 10,000 units.
According to Beckman Coulter, the firm has received complaints of erroneous Vitamin B12 results when using this reagent lot. The manufacturer states the affected lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing. The FDA classified the action as Class II.
Distribution was international, to Andorra, Bulgaria, Denmark, Estonia and other countries.
Laboratories should identify affected stock using the catalog number, UDI-DI and lot number above and follow the instructions issued by Beckman Coulter.
The recalled product
- Product
- Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 10,000
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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