The Binding Site Human Alpha-1-Antitrypsin Kit Recall: Low Control Risk
The Binding Site recalls Human Alpha-1-Antitrypsin Kit for SPAPlus analyser due to potential low control values affecting test accuracy. This may impact liver and lung condition diagnosis.
Lower-risk recall
The high control for the kit is recovering low and may be out of range for assigned values.
Contact the company
What happened, in plain English
The Binding Site is recalling a Human Alpha-1-Antitrypsin Kit for SPAPlus analyser (Product #NK034.S) because the test control may show low values that could be out of range. This might affect accurate diagnosis of liver conditions and pulmonary emphysema. Read more at govinfonow.com/recall/73125-the-binding-site-human-alpha-1-antitrypsin-kit-recall-low.
Source Summary by GovInfoNow · govinfonow.com/recall/73125-the-binding-site-human-alpha-1-antitrypsin-kit-recall-low · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0002-2018
Cite this page
“The Binding Site Human Alpha-1-Antitrypsin Kit Recall: Low Control Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73125-the-binding-site-human-alpha-1-antitrypsin-kit-recall-low. Based on FDA recall #Z-0002-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2018%22&limit=1).
Why it’s dangerous
The test control may show low values that could be out of range for assigned values. This might lead to inaccurate test results for Alpha-1-antitrypsin levels, which are used to diagnose liver conditions and pulmonary emphysema.
Who’s affected
People using this kit for lab testing of Alpha-1-antitrypsin levels, especially those diagnosing liver cirrhosis or pulmonary emphysema. Lab technicians and healthcare providers are most at risk.
How to tell if you have this one
Check for Product #NK034.S with Lot #400900, expired 12/31/2017, and UDI #05051700016421 on the label. The kit is designed for SPAPlus analyser use.
- Brand
The Binding Site- Category
Medical device
What to do — step by step
Check Kit Details
Verify the product number (NK034.S), lot number (400900), expiration date (12/31/2017), and unique device identifier (05051700016421) on the label.
Where it went and when
Where it was distributed
Distributed in California, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this kit?
No action is required beyond checking the kit details. The recall does not require immediate discontinuation.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0002-2018 (August 23, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0002-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.