CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
Id Now Covid-19 2.0 24t recalled by Abbott Diagnostics Scarborough
Abbott Diagnostics Scarborough is recalling Id Now Covid-19 2.0 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-1571-2025
- FDA event ID
- 96519
- 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
- Device Malfunction
- 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.
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
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.
Questions about this recall
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 No 192-000; GTIN/DI 10811877011351; Lot 000M884910 Model No 192-000; GTIN/DI 10811877011351; Lot 000M885121 Model No 192-000; GTIN/DI 10811877011351; Lot 000M911157 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913227 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913286 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913303 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913641 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914188 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914221 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914852 Model No 192-000; GTIN/DI 10811877011351; Lot 000M915373 Model No 192-000; GTIN/DI 10811877011351; Lot 000M916267 Model No 192-000; GTIN/DI 10811877011351; Lot 000M921404 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922204 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922578 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922601 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922634 Model No 192-000; GTIN/DI 10811877011351; Lot 000M924048 Model No 192-000; GTIN/DI 10811877011351; Lot 000M925615 Model No 192-000; GTIN/DI 10811877011351; Lot 000M938692 Model No 192-000; GTIN/DI 10811877011351; Lot 00M922634A Model No 192-000; GTIN/DI 10811877011351; Lot 00M924048A ****Updated 5/8/2025**** 04/29/2025 (Adding Additional Lots): Model No 192-000; GTIN/DI 10811877011351; Lot 000M913147 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913159 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922950 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922988 Model No 192-000; GTIN/DI 10811877011351; Lot 000M926188
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.
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.
Other products in this recall event
2 other products · FDA event 96519This product is part of a recall event; the main page for the event is ID NOW Influenza A/B 2 24T recalled by Abbott Diagnostics Scarborough.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ID NOW Influenza A/B 2 24T recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide | |
| CLASS II | Id Now Rsv 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide |
More recalls from Abbott Diagnostics Scarborough
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ID NOW" Influenza 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 2.0 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 |
| Device | CLASS II | Id Now Rsv 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide |
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