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

FDA device recall Z-1573-2025 · posted 2025-04-15 · Open, Classified

Recall details

Recalling firm

Abbott Diagnostics Scarborough, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

OCC

Quantity affected

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; Para

Date initiated

2025-03-04

Date posted

2025-04-15

Location

Scarborough, ME

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