CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report
Myla comprises Ast Filters in conjunction with Vitek MS recalled
Biomerieux is recalling Myla comprises Ast Filters in conjunction with Vitek MS, distributed nationwide in the US. The recall was initiated on 6 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1201-2023
- FDA event ID
- 91617
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2023
- FDA classified
- 2 Mar 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 6 Feb 2023 | Recall initiated by company | |
| 2 Mar 2023 | Classified by FDA | +24 days |
| 8 Mar 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
Questions about this recall
Is Myla comprises Ast Filters in conjunction with Vitek MS recalled?
Yes. Biomerieux recalled Myla comprises Ast Filters in conjunction with Vitek MS on 6 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1201-2023.
Why was it 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 lots are affected?
Versions 4.7 and 4.8
Where was it sold?
US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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