CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report

Binding Site Human IgM Kit (for Spaplus) recalled

The Binding Site Group is recalling Binding Site Human IgM Kit (for Spaplus), distributed in 10 states. The recall was initiated on 6 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 413849

Quantity recalled60

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0604-2019
FDA event ID: 81421
Recalling firm: The Binding Site Group, Birmingham, N/A
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2018
FDA classified: 13 Dec 2018
Reported: 19 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Nov 2018	Recall initiated by company
13 Dec 2018	Classified by FDA	+37 days
19 Dec 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,

California Florida Illinois Indiana Nebraska New York Pennsylvania South Dakota Virginia Washington

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot 413849

Where was it sold?

U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from The Binding Site Group

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