FDA Medical Device Recalls (openFDA)
Biomerieux Inc: VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
- Recall number
- Z-2353-2017
- Recalling firm
- Biomerieux Inc
- Product
- VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
- Status
- Terminated
- Initiated
- 2017-04-20
- Posted
- 2017-05-22
- Terminated
- 2020-07-22
- Reason
- The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- Root cause
- Packaging
- Action
- The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.
- Quantity
- 75,502 cartons
- Distribution
- Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
- Lot, serial or model codes
- 1320165103 10/May/18 1320172103 17/May/18 1320172203 17/May/18 1320179203 24/May/18 1320186103 31/May/18 1320193103 07/Jun/18 1320194103 08/Jun/18 1320215103 29/Jun/18 1320215203 29/Jun/18 1320222103 06/Jul/18 1320223103 07/Jul/18 1320242103 26/Jul/18 1320242203 26/Jul/18 1320249103 02/Aug/18 1320250103 03/Aug/18 1320256103 09/Aug/18 1320256203 09/Aug/18 1320257103 10/Aug/18 1320263103 16/Aug/18 1320264103 17/Aug/18 1320264203 17/Aug/18 1320277103 30/Aug/18 1320277203 30/Aug/18 1320284103 06/Sep/18 1320284203 06/Sep/18 1320285103 07/Sep/18 1320285203 07/Sep/18 1320291103 13/Sep/18 1320291203 13/Sep/18
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LON
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- 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