Recall Z-1144-2014
Focus Diagnostics Inc · initiated February 4, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Simplexa Flu AlB & RSV Direct Assay Kits, 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. Model Number MOL2650.
Codes / lots: Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.
Reason for recall
Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.
FDA-determined cause: Under Investigation by firm
Action taken
Focus Diagnostic initiated this recall on February 4, 2014 by sending recall notification letters to customers via email. The letter dated February 4, 2014, titled "URGENT: SAFETY NOTICE REMOVAL", informed customers of the recall (removal). The letter provided the following information: product description with code, reason for recall, the issue, the risk to health, recommendation, background, actions by customers, contact information, labeling, and response sheet.
Details
- Recall number
- Z-1144-2014
- Initiated
- February 4, 2014
- Posted by FDA
- March 5, 2014
- Terminated
- November 1, 2014
- Quantity
- 2,175 kits
- Distribution
- Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
- Recalling firm
- Focus Diagnostics Inc, Cypress, CA