Z-1619-2020Class II

C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456

Name: Z-1619-2020 C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456
Creator: The Binding Site Group, Ltd.
Published: 2019-04-25
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2019-04-25 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456 on 2019-04-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1619-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-25
Posted: 2020-03-31
Terminated: 2021-04-27
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,
Product code: DCN System, Test, C-Reactive Protein
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 1 kit
Distribution: U.S.: FL
Product codes and lots: Lot 455672

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1619-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1619-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-31

Product code DCN

K161982Class IIC-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group / cleared 2017-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)