MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use o
FDA device recall Z-2547-2020 · posted 2020-07-10 · Terminated
Recall details
- Recalling firm
- DiaSorin Molecular LLC
- Reason for recall
- Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
- Action taken
- On 05/12/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION LETTER" with an acknowledgement form to customers and distributors via email to inform them of an internal observed issue associated with the use of their Multi-Assay Suite (MAS) featured in the software version 2.0 where it may incorrectly apply the thresholds of the first loaded assay to the analytes coupled with the same dye in the second assay resulting in false negative or false positive results. The firm is instructing customers to: -Immediately discontinue the use of the MAS feature and that the issue will be correct in the new Software Version 2.1 which is expected to be release in June 2020. -Fill out the Response Form and return by either: -fax (562) 240-6526 Attention: Technical Services -email to: technical info.molecular@diasorin.com -mail to: ATTN: Technical Services, 11331 Valley View Street, Cypress, CA 90630 -Forward this communication to all required individuals with their organization. For further assistance with evaluating assay runs or for any questions, to contact Technical Services at +1-5672-240-6500, option 3 or via email ts.molecular@DiaSorin.com
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OQO
- Quantity affected
- 13943 plastic vials (24 vials per box)
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland.
- Date initiated
- 2020-05-12
- Date posted
- 2020-07-10
- Date terminated
- 2024-04-19
- Location
- Cypress, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K150962) | Focus Diagnostics | 2015-08-28 |
| SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (K141458) | Focus Diagnostics | 2014-07-01 |