FDA Device recall Z-0002-2018
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.,…
- FDA Device
- Class II
- terminated
- Published 2017-10-11
On 2017-10-11 the FDA classified a Class II recall of 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.,… by The Binding Site Group, citing the high control for the kit is recovering low and may be out of range for assigned values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0002-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-23 |
| Published | 2017-10-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | CA |
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
The high control for the kit is recovering low and may be out of range for assigned values.
Identifiers
| code_info | Lot #400900, Exp. 12/31/2017, UDI #05051700016421 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2021-07-14 · The Binding Site Group - Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
FDA Device · Class II · 2021-02-10 · The Binding Site Group - Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
FDA Device · Class II · 2020-06-03 · The Binding Site Group
All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2018%22
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