Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 21, 2017
VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomerieux Inc recalled VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton. - a moderate-severity action.
VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton. was recalled by Biomerieux Inc in June 21, 2017. Reason: The integrity of the product container may be compromised thereby exposing product to moisture which could le…. Check the official notice for the remedy. Verify recall #Z-2397-2017 with the FDA Devices before acting.
The recall
Biomerieux Inc issued this moderate-severity FDA Devices recall-The integrity of the product container may be compromised thereby exposing product to moisture which could le….
- Moderate
- severity level
- Class II
- classification
- June 21, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2397-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2397-2017) was formally reported on June 21, 2017, with the manufacturer initiating the action on April 20, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomerieux Inc is listed as the recalling firm, operating out of Hazelwood, MO. Federal records list the affected scope as 536 cartons.
The documented reason for this recall is: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Distribution data in the federal record shows the product reached: 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 - Herzegov…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
536 cartons
Related Recalls
6
3 from same agency
Product description
VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton.
Reason for recall
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2397-2017 |
| Date reported | June 21, 2017 |
| Date initiated | April 20, 2017 |
| Recalling firm | Biomerieux Inc |
| Firm location | Hazelwood, MO |
| Affected scope | 536 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,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2397-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton.. Recalled by Biomerieux Inc. Units affected: 536 cartons.
Why was this product recalled? ▼
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2397-2017.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2397-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 21, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.