CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
Legionella IFA Substrate Slide (IF0951) intended recalled
Focus Diagnostics is recalling Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and, distributed in California, New Jersey, Virginia. The recall was initiated on 15 Feb 2017 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-1686-2017
- FDA event ID
- 76619
- Recalling firm
- Focus Diagnostics, Cypress, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2017
- FDA classified
- 27 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Feb 2017 | Recall initiated by company | |
| 27 Mar 2017 | Classified by FDA | +40 days |
| 5 Apr 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
Product as listed by the FDA
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Where it was distributed
Product was distributed to three testing laboratories in California, New Jersey and Virginia
Questions about this recall
Is Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and recalled?
Yes. Focus Diagnostics recalled Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and on 15 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1686-2017.
Why was it recalled?
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
Which lots are affected?
IF0951: 10816101020055, lot numbers 29428, 31871
Where was it sold?
Product was distributed to three testing laboratories in California, New Jersey and Virginia
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 21 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 Focus Diagnostics
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Legionella IFA (IF0950) intended recalled by Focus Diagnostics | Focus Diagnostics | Other | CA, NJ, VA |
| Device | CLASS II | Simplexa Flu A/B & RSV Direct (MOL2650) recalled by Focus Diagnostics | Focus Diagnostics | Other | Nationwide |
| Device | CLASS I | Simplexa HSV 1&2 Direct (MOL2150) recalled by Focus Diagnostics | Focus Diagnostics | Other | Nationwide |
| Device | CLASS I | Simplexa Group A Strep Direct (MOL2850) recalled by Focus Diagnostics | Focus Diagnostics | Other | Nationwide |
| Device | CLASS II | Anaplasma Phagocytophilum IFA IgM Test Kit recalled by Focus Diagnostics | Focus Diagnostics | Other | CA |
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