CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
Optilite IgM Kit recalled by The Binding Site Group
The Binding Site Group is recalling Optilite IgM Kit, distributed in 28 states. The recall was initiated on 29 Jul 2019 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-1327-2020
- FDA event ID
- 84729
- Recalling firm
- The Binding Site Group, Birmingham
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2019
- FDA classified
- 19 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Jul 2019 | Recall initiated by company | |
| 19 Feb 2020 | Classified by FDA | +205 days |
| 26 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
Product as listed by the FDA
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Where it was distributed
CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,
AlabamaArkansasArizonaCaliforniaFloridaGeorgiaIowaIllinoisIndianaKentuckyMassachusettsMarylandMichiganMinnesotaNorth CarolinaNebraskaNew YorkOhioOregonPennsylvania
Questions about this recall
Why was it recalled?
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
Which lots are affected?
Lot # 422251
Where was it sold?
CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,
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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|---|---|---|---|---|---|
| Device | CLASS II | Exent Analyser recalled by The Binding Site Group | The Binding Site Group | Potency & Assay | Nationwide |
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