CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Myla software. Used to manage microbiology test workflow recalled
BioMerieux is recalling Myla software. Used to manage microbiology test workflow from the, distributed nationwide in the US. The recall was initiated on 22 Jun 2021 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-2225-2021
- FDA event ID
- 87985
- Recalling firm
- BioMerieux, Marcy L'Etoile, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jun 2021
- FDA classified
- 6 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 22 Jun 2021 | Recall initiated by company | |
| 6 Aug 2021 | Classified by FDA | +45 days |
| 18 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Where it was distributed
Distribution in the U.S. was nationwide. There was also military and government distribution.
Questions about this recall
Why was it recalled?
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Which lots are affected?
MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
Where was it sold?
Distribution in the U.S. was nationwide. There was also military and government distribution.
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 26 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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|---|---|---|---|---|---|
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