Medline Stat-Site B-HB Diluent Recalled for Potential Test Inaccuracy
Medline Industries is recalling Stat-Site B-HB Diluent because shipment compromise may cause false 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 is classified as FDA Class II and involves a risk of harm (false test results) where specific injury or illness has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medline Industries Inc is recalling Stat-Site B-HB Diluent, 6x 3ML, due to potential product compromise during shipment. The product is intended to be used with Stat-Site test strips or KetoSite test cards to dilute specimens containing high levels of B-hydroxybutyrate into the test range.
The recall is issued because the compromised product may lead to possible false negative or false positive test results. The affected lots are 163878, 192821, 191991, and 160795, with manufacturer number O202000. The product was distributed nationwide in the United States, specifically within the state of Ohio.
Consumers and healthcare providers should stop using the affected product and contact Medline Industries for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 24
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 (4)
- Lot #: 163878
- 192821
- 191991
- 160795 Manufacturer number:O202000
Distribution
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