Z-1573-2025Class II

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A...

Name: Z-1573-2025 Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A...
Creator: Abbott Diagnostics Scarborough, Inc.
Published: 2025-03-04
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2025-03-04 / Open, Classified / root cause: labeling and UDI

FDA source

Abbott Diagnostics Scarborough, Inc. began a recall of 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... on 2025-03-04. FDA classified it as Class II and gives the reason as "The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1573-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-04
Posted: 2025-04-15
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: 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
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: On March 4, 2025 FIELD CORRECTION NOTICE letters were sent to end user customers. Please complete the following actions, as applicable. 1. If you have impacted inventory in stock, then: " Discontinue use of and destroy any remaining inventory of the impacted lots according to your procedures. " Complete and return the Customer Reply Form (Form must be completed, signed and returned to receive a replacement lot). " Please retain this letter for your records. 2. If you have forwarded the product listed above to others in your network, then: - Inform them of this Field Correction Notice, provide to them a copy of this notice and request they take the necessary action. 3. If you do not have impacted inventory in stock, then: - All product lots not identified in Appendix I can continue to be used. If you have questions regarding this information, please contact Sedgwick by phone at 888 671 8858 (available 8am 5pm EST, Monday - Friday). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (1-800-332-1088), or by fax (1-800-FDA-0178). If you have experienced any patient or user injury associated with this Field Correction Notice, please immediately report the event to your local area Customer Service. ****Update added 5/8/2025**** On April 29, 2025 FIELD CORRECTION NOTICE letters were sent to customers informing them of additional lots included in this recall.
Quantity in commerce: 178056 eaches (147472 US, 31584 OUS)
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1573-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1571-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1572-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1573-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15

Product code OCC

K161375Class IIAlere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. / cleared 2016-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)