Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 8, 2023
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomerieux Inc recalled MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects micro… - a moderate-severity action.
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects micro… was recalled by Biomerieux Inc in March 8, 2023. Reason: For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filt…. Check the official notice for the remedy. Verify recall #Z-1201-2023 with the FDA Devices before acting.
The recall
Biomerieux Inc issued this moderate-severity FDA Devices recall-For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filt….
- Moderate
- severity level
- Class II
- classification
- March 8, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1201-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1201-2023) was formally reported on March 8, 2023, with the manufacturer initiating the action on February 6, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Biomerieux Inc is listed as the recalling firm, operating out of Hazelwood, MO. Federal records list the affected scope as 19 systems.
The documented reason for this recall is: For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the … Distribution data in the federal record shows the product reached: US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.. 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
19 systems
Related Recalls
6
3 from same agency
Product description
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Reason for recall
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1201-2023 |
| Date reported | March 8, 2023 |
| Date initiated | February 6, 2023 |
| Recalling firm | Biomerieux Inc |
| Firm location | Hazelwood, MO |
| Affected scope | 19 systems |
| Distribution | US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico. |
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-1201-2023) 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? ▼
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).. Recalled by Biomerieux Inc. Units affected: 19 systems.
Why was this product recalled? ▼
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1201-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1201-2023) 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 March 8, 2023. 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.