Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser — Class II medical device recall Z-0002-2018
Terminated recall by The Binding Site Group, Ltd., reported 2017-10-11, distributed in CA. The high control for the kit is recovering low and may be out of range for assigned values.
| Recall number | Z-0002-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom |
| Recall initiated | 2017-08-23 |
| Classified | 2017-10-04 |
| Reported by FDA | 2017-10-11 |
| Terminated | 2019-02-21 |
| Distributed | CA |
| Countries outside the US | AR, BE, BG, CO, CZ, DE, FR, GB, IR, PA, RO, SA, TR |
| Quantity | 361 kits |
| UPC / GTIN / UDI-DI | 05051700016421 |
| Lot numbers | 400900 |
| Expiration dates | 2017-12-31 |
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 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.
Reason for recall
The high control for the kit is recovering low and may be out of range for assigned values.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0002-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.