FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
- Recall number
- Z-0298-04
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
- Status
- Terminated
- Initiated
- 2003-11-26
- Posted
- 2004-01-06
- Terminated
- 2004-02-20
- Reason
- Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
- Root cause
- Other
- Action
- Customers notified via phone and faxed letter on 11/26/03. Customers provided with a modified QC procedure to be used until new shipments can be made.
- Quantity
- 774 reagent packs
- Distribution
- 738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.
- Lot, serial or model codes
- Lot 611, Exp. 25 June 2004
- 510(k) numbers
- ["K993068"]
- PMA numbers
- not on file
- Product code
- JHX
- 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