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U.S. Department of Health and Human Services

Class 1 Device Recall Simplexa Group A Strep Direct

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  Class 1 Device Recall Simplexa Group A Strep Direct see related information
Date Initiated by Firm February 10, 2016
Date Posted April 02, 2016
Recall Status1 Terminated 3 on June 16, 2016
Recall Number Z-1274-2016
Recall Event ID 73283
510(K)Number K143651  
Product Classification Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system - Product Code PGX
Product Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)

Model Number: MOL2850, MOL1451, MOL1452, MOL1455
Code Information 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.  
Recalling Firm/
Manufacturer		 Focus Diagnostics Inc
11331 Valley View St
Cypress CA 90630-5366
For Additional Information Contact Valerie Cimmarusti
562-240-6484
Manufacturer 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 2		 Under Investigation by firm
Action 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,
Quantity in Commerce 41 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PGX and Original Applicant = FOCUS DIAGNOSTICS, INC.
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