Binding Site Alpha-1-Antitrypsin Kit Recalled for Low Control Recovery
The Binding Site Group is recalling 361 Human Alpha-1-Antitrypsin Kits because the high control may recover low and fall out of range.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling 361 units of the Human Alpha-1-Antitrypsin Kit (Product #NK034.S) for use on the SPAPlus analyser. The recall is limited to Lot #400900, which has an expiration date of 12/31/2017 and UDI #05051700016421.
The recall was initiated because the high control for the kit is recovering low and may be out of range for assigned values. This product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum to aid in the diagnosis of conditions such as adult cirrhosis of the liver and pulmonary emphysema.
The affected kits were distributed worldwide, including in the United States (California) and in the United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey, Romania, Colombia, and Saudi Arabia. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS…
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 361
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 (3)
- Lot #400900
- Exp. 12/31/2017
- UDI #05051700016421
Distribution
Distributed in 1 state:
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