FDA Medical Device Recalls (openFDA)
Hardy Media Inc Dba Hardy Diag: Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338
- Recall number
- Z-0542-04
- Recalling firm
- Hardy Media Inc Dba Hardy Diag
- Product
- Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338
- Status
- Terminated
- Initiated
- 2003-12-31
- Posted
- 2004-02-24
- Terminated
- 2004-05-17
- Reason
- Mislabeled.
- Root cause
- Other
- Action
- Customers were first notified by telephone on 12/31/2003. Then customers are mailed a sigh\ned recall letter via first class mail. All customers will be contacted by telephone to reconcile returns.
- Quantity
- 39 bottles of Z71 and 6 bottles of Z72
- Distribution
- TX, CA, ID, Puerto Rico, KS, WY,
- Lot, serial or model codes
- Lot 3338.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTO
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- 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