Diagnostic Hybrids Recalls MicroVue BAP EIA Kits Due to Leaking Bottles
Diagnostic Hybrids, Inc. is recalling 1004 units of the MicroVue BAP EIA Model 8012 because standard bottles may have low volume or leak.
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 FDA classification is Class II, which typically indicates a moderate risk. The hazard involves potential leaking bottles, which constitutes a quality defect rather than a direct health threat like contamination or injury in this context.
Plain-English summary
Diagnostic Hybrids, Inc. has initiated a recall of the MicroVue BAP EIA, Model 8012. This product provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum. The recall affects 1004 units associated with lot number 067850.
The reason for the recall is the possibility of low volume and/or leaking standard bottles within the affected lots. No other hazards or reported injuries are mentioned in the source text.
The recalled products were distributed to US states including CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI, as well as foreign countries such as Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.
Consumers or facilities possessing these specific lots should review the official recall notice for instructions on how to return or dispose of the product.
The recalled product
- Product
- MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
- Manufacturer
- Diagnostic Hybrids, Inc.
- Affected units
- 1,004
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 (1)
- Lot 067850
Distribution
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