Recall Z-1272-2016
Focus Diagnostics Inc · initiated February 10, 2016
Class I – dangerous or defective products that could cause serious health problems or death
Product
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
Codes / lots: Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262. Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620. 3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 Technicalinfo@focusdx.com 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,
Details
- Recall number
- Z-1272-2016
- Initiated
- February 10, 2016
- Posted by FDA
- April 2, 2016
- Terminated
- June 16, 2016
- Product code
- PGH – Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Quantity
- 1845 units
- 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.
- Recalling firm
- Focus Diagnostics Inc, Cypress, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1273-2016 Class II | Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451…Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2… | 02/10/2016Terminated |
| Z-1274-2016 Class I | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451…Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2… | 02/10/2016Terminated |