Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 18, 2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomerieux Inc recalled Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. … - a critical-severity action.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. … was recalled by Biomerieux Inc in May 18, 2016. Reason: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.. Check the official notice for the remedy. Verify recall #Z-1645-2016 with the FDA Devices before acting.
The recall
Biomerieux Inc issued this critical-severity FDA Devices recall-Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin..
- Critical
- severity level
- Class I
- classification
- May 18, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1645-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1645-2016) was formally reported on May 18, 2016, with the manufacturer initiating the action on February 24, 2016. It is classified under Critical severity (Class I), 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 5,575 kits.
The documented reason for this recall is: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. Distribution data in the federal record shows the product reached: Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5,575 kits
Related Recalls
6
3 from same agency
Product description
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Reason for recall
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1645-2016 |
| Date reported | May 18, 2016 |
| Date initiated | February 24, 2016 |
| Recalling firm | Biomerieux Inc |
| Firm location | Hazelwood, MO |
| Affected scope | 5,575 kits |
| Distribution | Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey. |
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-1645-2016) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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 Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.. Recalled by Biomerieux Inc. Units affected: 5,575 kits.
Why was this product recalled? ▼
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Critical. Recall number: Z-1645-2016.
Where was the recalled product distributed? ▼
Distribution: Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1645-2016) 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 May 18, 2016. 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.