Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 11, 2016
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinati
Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
Biomerieux Inc recalled VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bio… — a moderate-severity action.
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bio… was recalled by Biomerieux Inc in May 11, 2016. Reason: Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae t…. Check the official notice for the remedy. Verify recall #Z-1596-2016 with the FDA Devices before acting.
The recall
Biomerieux Inc issued this moderate-severity FDA Devices recall — Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae t….
- Moderate
- severity level
- Class II
- classification
- May 11, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1596-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1596-2016) was formally reported on May 11, 2016, with the manufacturer initiating the action on February 24, 2016. 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 337 Kits of 20 Cards/Kit.
The documented reason for this recall is: Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline. Distribution data in the federal record shows the product reached: Worldwide Distribution to China Taiwan region; No US/military/government distribution.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
337 Kits of 20 Cards/Kit
Related Recalls
6
6 from same agency
Product description
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the 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 may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1596-2016 |
| Date reported | May 11, 2016 |
| Date initiated | February 24, 2016 |
| Recalling firm | Biomerieux Inc |
| Firm location | Hazelwood, MO |
| Affected scope | 337 Kits of 20 Cards/Kit |
| Distribution | Worldwide Distribution to China Taiwan region; No US/military/government distribution. |
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-1596-2016) 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.
- 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 Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the 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: 337 Kits of 20 Cards/Kit.
Why was this product recalled? ▼
Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2016. Severity: Moderate. Recall number: Z-1596-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution to China Taiwan region; No US/military/government distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1596-2016) 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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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 11, 2016.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.