Z-0477-2019Class II

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

Name: Z-0477-2019 Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM...
Creator: The Binding Site Group, Ltd.
Published: 2018-07-25
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2018-07-25 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of 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... on 2018-07-25. FDA classified it as Class II and gives the reason as "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...". 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-0477-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-25
Posted: 2018-11-17
Terminated: 2021-04-27
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.
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 108
Distribution: U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA
Product codes and lots: Lot: 407483-1 and 407483-2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0477-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0477-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-16

Product code CFN

K082129Class IIHuman Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerThe Binding Site, Ltd. / cleared 2009-02-10

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)