FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
- Recall number
- Z-1385-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
- Status
- Terminated
- Initiated
- 2006-07-25
- Posted
- 2006-08-09
- Terminated
- 2007-04-18
- Reason
- The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)
- Root cause
- Other
- Action
- Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.
- Quantity
- 20 kits.
- Distribution
- Nationwide including the states of Arizona, California, New Jersey and Pennsylvania.
- Lot, serial or model codes
- Lot 674653; exp. 12/31/2006.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GTQ
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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