Abbott Diagnostics Scarborough, Inc.: 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

Recall number

Z-1573-2025

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

Status

Open, Classified

Initiated

2025-03-04

Posted

2025-04-15

Terminated

not on file

Reason

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

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

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.

Lot, serial or model codes

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

510(k) numbers

K161375

PMA numbers

not on file

Product code

OCC

Firm FEI

1221359

Firm city

Scarborough

Firm state

ME

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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