Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intende

FDA device recall Z-0846-2014 · posted 2014-01-28 · Terminated

Recall details

Recalling firm

Focus Diagnostics Inc

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.

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.

Root cause

Pending

Status

Terminated

Product code

OCC

Quantity affected

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

Date initiated

2014-01-10

Date posted

2014-01-28

Date terminated

2014-10-15

Location

Cypress, CA

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