CLASS II Device recall · Reported 11 Apr 2018 · FDA Enforcement Report
Binding Site Optilite Beta-2-Microglobulin Urine Kit recalled
The Binding Site Group is recalling Binding Site Optilite Beta-2-Microglobulin Urine Kit, distributed in California. The recall was initiated on 9 Mar 2018 and the FDA has classified it as Class II.
Check your package
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-1301-2018
- FDA event ID
- 79499
- Recalling firm
- The Binding Site Group, Birmingham, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2018
- FDA classified
- 3 Apr 2018
- Reported
- 11 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Mar 2018 | Recall initiated by company | |
| 3 Apr 2018 | Classified by FDA | +25 days |
| 11 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Product as listed by the FDA
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
Where it was distributed
US Distribution was made to CA. There was no foreign/military/government distribution.
Questions about this recall
Why was it recalled?
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Which lots are affected?
Lot 407460, UDI 05051700017688
Where was it sold?
US Distribution was made to CA. There was no foreign/military/government distribution.
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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|---|---|---|---|---|---|
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