Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum,

FDA device recall Z-0477-2019 · posted 2018-11-17 · Terminated

Recall details

Recalling firm

The Binding Site Group, Ltd.

Reason for recall

After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.

Action taken

On 07/25/2018, the Urgent Field Safety Notice and Field Correction E-back Form were emailed to customers. Customers were advised to cease use of the affected product and to dispose of the kits locally. This notice states that a witness signature of kit disposal is required on the E-back form. This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. Customers with additional questions are encouraged to contact their local firm representative, or customer service via phone at +44(0) 1214569696, or email at Technical.support@bindingsite.co.uk. The E-back Form requests that each customer and witness sign and date confirming they have both received and have followed the advice issued in the Notification. It also asks for the number of product in stock and number of kits disposed.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CFN

Quantity affected

108

Distribution

U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA

Date initiated

2018-07-25

Date posted

2018-11-17

Date terminated

2021-04-27

Location

Birmingham, United Kingdom

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