Recall Z-1686-2017
Focus Diagnostics Inc · initiated February 15, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Codes / lots: IF0951: 10816101020055, lot numbers 29428, 31871
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.
FDA-determined cause: No Marketing Application
Action taken
Focus Diagnostics/DiaSorin Molecular is issuing a medical device correction for the Legionella IFA (Immuno Fluoresence Assay). On February 1, 2017, the firm was notified that the Legionella IFA was not properly classified according to 21 CFR Part 807. The product is being withdrawn from the market. Use of the product should be immediately discontinued, and any remaining inventory should be immediately destroyed. The firm sent notice to its consignees, which should be reviewed with the facility's laboratory or mediclal director. Patient results obtained with all lots of the affected product should be evaluated by the clinician and if recommended, retested by another method.
Details
- Recall number
- Z-1686-2017
- Initiated
- February 15, 2017
- Posted by FDA
- March 27, 2017
- Terminated
- April 13, 2017
- Product code
- LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
- Quantity
- 1,400 units
- Distribution
- Product was distributed to three testing laboratories in California, New Jersey and Virginia
- Recalling firm
- Focus Diagnostics Inc, Cypress, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1685-2017 Class II | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human…After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found… | 02/15/2017Terminated |