FDA Medical Device Recalls (openFDA)
Biomerieux Inc: VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
- Recall number
- Z-2341-2017
- Recalling firm
- Biomerieux Inc
- Product
- VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 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
- 177,828 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
- 241396010 17/Oct/17 241398120 07/Nov/17 241398420 10/Nov/17 241398620 12/Nov/17 241398720 13/Nov/17 241398820 14/Nov/17 241399520 21/Nov/17 2410000203 26/Nov/17 2410002203 28/Nov/17 2410006203 02/Dec/17 2410007203 03/Dec/17 2410008203 04/Dec/17 2410009103 05/Dec/17 2410031103 27/Dec/17 2410033103 29/Dec/17 2410034103 30/Dec/17 2410037103 02/Jan/18 2410038103 03/Jan/18 2410041103 06/Jan/18 2410042103 07/Jan/18 2410043103 08/Jan/18 2410044203 09/Jan/18 2410047203 12/Jan/18 2410052103 17/Jan/18 2410057103 22/Jan/18 2410058103 23/Jan/18 2410063103 28/Jan/18 2410064103 29/Jan/18 2410065103 30/Jan/18 2410071103 05/Feb/18 2410072103 06/Feb/18 2410078103 12/Feb/18 2410083103 17/Feb/18 2410085203 19/Feb/18 2410086103 20/Feb/18 2410088103 22/Feb/18 2410091203 25/Feb/18 2410092103 26/Feb/18 2410093103 27/Feb/18 2410097103 03/Mar/18 2410098103 04/Mar/18 2410099103 05/Mar/18 2410100103 06/Mar/18 2410105203 11/Mar/18 2410106103 12/Mar/18 2410107203 13/Mar/18
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LQM
- 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