FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
- Recall number
- Z-0477-2019
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
- Status
- Terminated
- Initiated
- 2018-07-25
- Posted
- 2018-11-17
- Terminated
- 2021-04-27
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 108
- Distribution
- U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA
- Lot, serial or model codes
- Lot: 407483-1 and 407483-2
- 510(k) numbers
- ["K082129"]
- PMA numbers
- not on file
- Product code
- CFN
- 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