FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456
- Recall number
- Z-1619-2020
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
- Status
- Terminated
- Initiated
- 2019-04-25
- Posted
- 2020-03-31
- Terminated
- 2021-04-27
- Reason
- A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
- Root cause
- Nonconforming Material/Component
- Action
- On 4/25/2019, a Customer Notice was issued by the firm's UK office to firm's US office. The US office was instructed to provide this information to the end customer within 24 hours of receiving the notification along with a form to fill out and return. The Customer Notice issued to the affected customer advises immediate quarantine and disposal of affected kits following local regulations. Customers were asked to pass on the customer notice and to all those who need to be aware within their organization or to any organization where potentially affected devices have been transferred. The customer notice requests the customer to complete, sign and return the e-back form. This confirms receipt of the Customer Notice, the number of kits disposed of and that the advice has been followed, along with a witness signature. Firm requests that e-back form be returned to Technical.support@bindingsite.com or to a local firm representative within one week. Should you require additional information, contact your local representative or Technical Support Group at UK: +44(0) 1214569696.
- Quantity
- 1 kit
- Distribution
- U.S.: FL
- Lot, serial or model codes
- Lot 455672
- 510(k) numbers
- ["K161982"]
- PMA numbers
- not on file
- Product code
- DCN
- Firm FEI
- 3002808340
- Firm city
- Birmingham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28