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

FDA device recall Z-1619-2020 · posted 2020-03-31 · Terminated

Recall details

Recalling firm

The Binding Site Group, Ltd.

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DCN

Quantity affected

1 kit

Distribution

U.S.: FL

Date initiated

2019-04-25

Date posted

2020-03-31

Date terminated

2021-04-27

Location

Birmingham, United Kingdom

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