Z-0604-2019Class II

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

Name: Z-0604-2019 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: 2018-11-06
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2018-11-06 / 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 2018-11-06. FDA classified it as Class II and gives the reason as "Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges". 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-0604-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-06
Posted: 2018-12-13
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: Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On 11/06/2018, the firm, The Binding Site, emailed an "Urgent Medical Device Correction notice" and Field Correction E-back Form to customers. The notice described the product, problem and actions to be taken. Customers were instructed to do the following: 1) Reagents are to be loaded on-board the analyser and left for a minimum of 18 hours prior to running the calibration and validating the curve. Please leave the reagents on-board the analyser until empty. 2) Once calibration is established and validated, reagents must remain on the instrument until the reagent has been fully consumed. 3) When not in use the control vials and calibrator sets should be removed from the instrument, be capped to avoid evaporation and stored at 2-8 degrees C. 4) To be able to accept the calibration curve and to use the assay to report test results, the control materials to be tested at a minimum once a day should return results within 15% of the concentration(s) as stated on the accompanying QC certificate. If a control measurement is out of range when assayed with a stored curve the assay must be recalibrated. If on recalibration the control values measured with the new curve are still out of range, the instrument and the assay parameters should be checked before repeating the assay. 5) If calibration issues are still experienced when following this advice please do not hesitate to contact a firm representative. The E-back Form requests that each customer sign the form confirming they have both received and have followed the advice issued in the Notification; and return completed E-back form to [email protected] or your local Binding Site Representative. This notice needs to be passed on 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 phon
Quantity in commerce: 60
Distribution: U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
Product codes and lots: Lot 413849

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0604-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0604-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-13

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)