CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
ID NOW Influenza A/B 2 24T recalled by Abbott Diagnostics Scarborough
Abbott Diagnostics Scarborough is recalling ID NOW Influenza A/B 2 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-1575-2025
- 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
- Test Kits & Diagnostics
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 Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is ID NOW Influenza A/B 2 24T recalled?
Yes. Abbott Diagnostics Scarborough recalled ID NOW Influenza A/B 2 24T on 4 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1575-2025.
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 427-000; GTIN/DI 10811877010422; Lot 000M889669 Model 427-000; GTIN/DI 10811877010422; Lot 000M890889 Model 427-000; GTIN/DI 10811877010422; Lot 000M916327 Model 427-000; GTIN/DI 10811877010422; Lot 000M916649 Model 427-000; GTIN/DI 10811877010422; Lot 000M916672 Model 427-000; GTIN/DI 10811877010422; Lot 000M916724 Model 427-000; GTIN/DI 10811877010422; Lot 000M917131 Model 427-000; GTIN/DI 10811877010422; Lot 000M917164 Model 427-000; GTIN/DI 10811877010422; Lot 000M917180 Model 427-000; GTIN/DI 10811877010422; Lot 000M917508 Model 427-000; GTIN/DI 10811877010422; Lot 000M917581 Model 427-000; GTIN/DI 10811877010422; Lot 000M919907 Model 427-000; GTIN/DI 10811877010422; Lot 000M921626 Model 427-000; GTIN/DI 10811877010422; Lot 000M921636 Model 427-000; GTIN/DI 10811877010422; Lot 000M921728 Model 427-000; GTIN/DI 10811877010422; Lot 000M923485 Model 427-000; GTIN/DI 10811877010422; Lot 000M926234 Model 427-000; GTIN/DI 10811877010422; Lot 000M926370 Model 427-000; GTIN/DI 10811877010422; Lot 000M927991 Model 427-000; GTIN/DI 10811877010422; Lot 000M928421 Model 427-000; GTIN/DI 10811877010422; Lot 000M929248 Model 427-000; GTIN/DI 10811877010422; Lot 000M931072 Model 427-000; GTIN/DI 10811877010422; Lot 000M934181 Model 427-000; GTIN/DI 10811877010422; Lot 000M939117 Model 427-000; GTIN/DI 10811877010422; Lot 000M939160 Model 427-000; GTIN/DI 10811877010422; Lot 000M939186 Model 427-000; GTIN/DI 10811877010422; Lot 000M939468 Model 427-000; GTIN/DI 10811877010422; Lot 000M939480 Model 427-000; GTIN/DI 10811877010422; Lot 000M952883
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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