Recall Z-1272-2016— Focus Diagnostics Inc
Class I · Terminated
Class I FDA medical device recall by Focus Diagnostics Inc, initiated 2016-02-10, terminated 2016-06-16. It names 2 FDA 510(k) clearances: K150962, K141458. Product: Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455. Reason: Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates..
- Recalling firm
- Focus Diagnostics Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-02-10
- Terminated
- 2016-06-16
- Firm location
- Cypress, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
Reason for recall
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Data sourced from openFDA. This site is unofficial and independent of the FDA.