Recall Z-0846-2014
Focus Diagnostics Inc · initiated January 10, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Codes / lots: Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.
Reason for recall
Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.
FDA-determined cause: Pending
Action taken
Focus Diagnostics sent an Urgent Safety Notice Correction letter dated January 10, 2014, via email and a hard copy letter by mail. The letter informed customers of the correction, product description with codes, product intended use, issue, risk to health, background, recommendation, actions by customers, and contact information. Customers were instructed to check their inventory for the affected product, if customers detect any positive RSV results, confirm the positive result by an alternate method. Customers were asked to complete the "URGENT: SAFETY NOTICE Acknowledgement and Receipt Form Response Required". Customers with questions were instructed to contact their Technical Services department at 800-838-4548, select option 3. For questions regarding this recall call 714-220-1900.
Details
- Recall number
- Z-0846-2014
- Initiated
- January 10, 2014
- Posted by FDA
- January 28, 2014
- Terminated
- October 15, 2014
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Quantity
- 1,052 kits
- Distribution
- Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .
- Recalling firm
- Focus Diagnostics Inc, Cypress, CA