FDA Medical Device Recalls (openFDA)
LumiQuick Diagnostics Inc.: Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
- Recall number
- Z-1346-2014
- Recalling firm
- LumiQuick Diagnostics Inc.
- Product
- Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
- Status
- Terminated
- Initiated
- 2014-03-04
- Posted
- 2014-04-07
- Terminated
- 2014-05-09
- Reason
- Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
- Root cause
- No Marketing Application
- Action
- Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
- Quantity
- ALL
- Distribution
- Distributed in the states of CA, FL, NJ, TX, and NY.
- Lot, serial or model codes
- Catalog number: 71033, All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3005984081
- Firm city
- Santa Clara
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28