FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
- Recall number
- Z-0558-03
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
- Status
- Terminated
- Initiated
- 2003-01-10
- Posted
- 2003-02-21
- Terminated
- 2003-06-03
- Reason
- Label printing irregularities on cartons and/or bottles.
- Root cause
- Other
- Action
- Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.
- Quantity
- 284 cartons/2 bottles per carton
- Distribution
- Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.
- Lot, serial or model codes
- Lot 5003, Exp. 12 September 2003
- 510(k) numbers
- ["K964310"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- 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