CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
Id Now Rsv 24t recalled by Abbott Diagnostics Scarborough
Abbott Diagnostics Scarborough is recalling Id Now Rsv 24t, distributed nationwide in the US. The recall was initiated on 4 Mar 2025 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-1576-2025
- FDA event ID
- 96500
- Recalling firm
- Abbott Diagnostics Scarborough, Scarborough, ME
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2025
- FDA classified
- 15 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- CPAP & Ventilators
Timeline
| 4 Mar 2025 | Recall initiated by company | |
| 15 Apr 2025 | Classified by FDA | +42 days |
| 23 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
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
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Id Now Rsv 24t recalled?
Yes. Abbott Diagnostics Scarborough recalled Id Now Rsv 24t on 4 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1576-2025.
Why was it recalled?
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Which lots are affected?
Model 435-000; GTIN/DI 10811877010521; Lot 000M906790 Model 435-000; GTIN/DI 10811877010521; Lot 000M907271 Model 435-000; GTIN/DI 10811877010521; Lot 000M923531 Model 435-000; GTIN/DI 10811877010521; Lot 000M923879 Model 435-000; GTIN/DI 10811877010521; Lot 000M924414 Model 435-000; GTIN/DI 10811877010521; Lot 000M924430 Model 435-000; GTIN/DI 10811877010521; Lot 000M926642 Model 435-000; GTIN/DI 10811877010521; Lot 000M926679 Model 435-000; GTIN/DI 10811877010521; Lot 000M927161
Where was it sold?
US Nationwide 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 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.
More recalls from Abbott Diagnostics Scarborough
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ID NOW" Influenza A & B recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Device Malfunction | Nationwide |
| Device | CLASS II | Id Now Covid-19 0 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Device Malfunction | Nationwide |
| Device | CLASS II | Id Now Rsv 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide |
| Device | CLASS II | Id Now Covid-19 0 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Device Malfunction | Nationwide |
| Device | CLASS II | ID NOW Influenza A/B 2 24T recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide |
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| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
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| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |