CLASS II Device recall · Reported 6 Apr 2022 · FDA Enforcement Report
Pneumonia (33 Targets) Control Panel recalled by Microbiologics
Microbiologics is recalling Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing, distributed in 8 states. The recall was initiated on 3 Mar 2022 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-0844-2022
- FDA event ID
- 89746
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2022
- FDA classified
- 31 Mar 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Mar 2022 | Recall initiated by company | |
| 31 Mar 2022 | Classified by FDA | +28 days |
| 6 Apr 2022 | 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
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Where it was distributed
US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
AlabamaGeorgiaIllinoisMontanaPennsylvaniaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Which lots are affected?
Catalog Number 8244, UDI: 70845357043664, Lot Number (Expiration Date) (New Expiration Date): 8244 01 (07/31/2022) (07/26/2021), 8244 02 (08/31/2022) (08/02/2021)
Where was it sold?
US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
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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