FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
- Recall number
- Z-2498-2021
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
- Status
- Terminated
- Initiated
- 2021-08-04
- Posted
- not on file
- Terminated
- 2024-02-23
- Reason
- Customers have reported an increased number of false positive SARS-CoV-2 results.
- Root cause
- Under Investigation by firm
- Action
- On August 4, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were instructed to take the following actions: - Immediately discontinue the use of the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat system, lot number 10119Z. - For handling previous positive results generated with the cobas SARS-CoV-2 & Influenza A/B test for use on the cobas Liat system, follow your laboratory s standard operating procedures to investigate the potential for false positive results. Please consult with the physician or clinicians at your facility to determine specific clinical implications for your patients. - Repeat testing can be performed using other cobas SARS-CoV-2 & Influenza A/B lot numbers. - Complete all sections of the enclosed faxback form and fax it to 1-888-312-5960 or email it to Roche4691@stericycle.com. - Discard lot number 10119Z according to your local waste management ordinance. - File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-800-5973 if you have questions about this recall.
- Quantity
- 211 kits (US); 3073 kits (OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
- Lot, serial or model codes
- Lot 10119Z
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QLT
- Firm FEI
- 2243471
- Firm city
- S Branchburg
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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