Human Alpha-1-Antitrypsin Kit for use on the SPAPlus… recallZ-0002-2018 · The Binding Site Group, Ltd. · initiated Aug 23, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The high control for the kit is recovering low and may be out of range for assigned values.
FDA root cause category: Under Investigation by firm
What the company is doing
Binding Site sent an Field Safety Notice dated August 24, 2017, explaining the reason for recall and requesting the direct account and their customer to remove the affected kits from inventory and dispose of them. The direct account and their customers were instructed to circulate the field safety notice to other persons who use the product within their organization. A response form, to be returned via email, was enclosed for completion to indicate the number of kits discarded. For further questions, please call (858) 453-9177.
Recall details
- Recall number
- Z-0002-2018
- Status
- Terminated
- Initiated by the company
- Aug 23, 2017
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 361 kits
- Product code
- DEM
- FDA submissions
- K123256
- 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.
Product description
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 turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Code information (models, lots, serial numbers)
Lot #400900, Exp. 12/31/2017, UDI #05051700016421
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Human alpha 1 antitrypsin Kit for use on SPAPLUS NK034.SThe Binding Site Group Limited · Alpha-1-Antitrypsin, Antigen, Antiserum, Control1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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