FDA Medical Device Recalls (openFDA)
ORTHO-CLINICAL DIAGNOSTICS: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- Recall number
- Z-2357-2023
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Product
- VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- Status
- Open, Classified
- Initiated
- 2023-06-05
- Posted
- 2023-08-08
- Terminated
- not on file
- Reason
- Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
- Root cause
- Process control
- Action
- Customers were sent a recall notification by mail dated 06/05/2023. The notification that customers immediately discontinue use of affected devices and discard any remaining inventory. Any discarded product will be replaced by QuidelOrtho or credit will be provided. Customers are asked to return the provided Confirmation of Receipt Form no later than 06/12/2023. If affected devices were further distributed customers are asked to forward the provided notification to those downstream customers. This notice is to be posted by all VITROS Systems until the expiration of affected devices, which is 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.
- Quantity
- 4,013 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023.
- 510(k) numbers
- ["K062838","K992366"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 3007111389
- Firm city
- Bridgend
- Firm state
- not on file
- Firm country
- United Kingdom
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