FDA Medical Device Recalls (openFDA)
Focus Diagnostics Inc: 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.
- Recall number
- Z-1144-2014
- Recalling firm
- Focus Diagnostics Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-02-04
- Posted
- 2014-03-05
- Terminated
- 2014-11-01
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 2,175 kits
- Distribution
- Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
- Lot, serial or model codes
- Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OOC
- Firm FEI
- 2023365
- Firm city
- Cypress
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06