Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification… recallZ-1272-2016 · Focus Diagnostics Inc · initiated Feb 10, 2016

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

A customer notification letter dated 2/10/16 was sent to all their customers who received 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). The letter informs the customers that Focus Diagnostics is recalling MOL2150 and MOL2650 kits because it may result in a false negative result, a false positive result or Error Code(s) 500 or 505. Additionally, some customers are reporting insufficient specimen volume errors which may result in higher invalid rates. In those cases, the error results in a Report Note Statement of Insufficient Specimen Volume. The letter informs the customers of the recommendations to be taken for the identified kits and the risks involved for positive results, negative results, and delayed results. The letter informs the customers of the actions to be taken. Customers are instructed to sign the achnowledgement form and email the form to [email protected] or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. On 2/11/16, Focus Diagnostics sent to their customers an amendment to the customer notification letter to clarify what is considered an "early Ct", Focus would consider Internal Control (IC) Ct's less than 25 as "early Ct". Customers are informed that if an internal control Ct is less than 25, additional testing may be necessary. On 2/15/16, Focus Diagnostics sent to their customers an amendment to the customer notification letter to inform them to determine if they had instances of early Cts less than 25, then to please refer to Section III Analyzing Runs, pages 6-10 and 6-15 in the Focus Diagnostics, Operator Manual for Integrated Cycler Studio 6.0 For Use with IVD Assays in the USA. Also, for a more detailed analysis, customers are instructed to view excerpts from the ICS Operator Manual covering Section III, pages 6-10 and 6-16. On 3/17/16,

Recall details

Recall number

Z-1272-2016

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Feb 10, 2016

Posted by the FDA

Apr 2, 2016

Recalling firm

Focus Diagnostics Inc

Quantity

1845 units

Product code

PGH

FDA submissions

K141458, K150962

Distribution

Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.

Product description

Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455

Other devices under the same FDA submission

1 device cleared under K141458, K150962 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Simplexa™ HSV 1 & 2 Direct MOL2150

  Diasorin Molecular LLC · Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
  1 death1 report