FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems.
- Recall number
- Z-1263-2015
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems.
- Status
- Terminated
- Initiated
- 2014-12-29
- Posted
- 2015-03-11
- Terminated
- 2017-03-27
- Reason
- In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended.
- Root cause
- Software design
- Action
- On 12/29/2014, Customer letter (Ref. CL2014-315) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and provided with instructions for reconfiguring their Barcode Scanners.
- Quantity
- Domestic: 62 units; Foreign: 10 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Australia and England.
- Lot, serial or model codes
- Lot Numbers: 0914F11968, 0914F11969, 0914F11970, 0914F11971, 0914F11972, 0914F11973, 0914F11974, 0914F11975, 0914F11976, 0914F11977, 0914F11978, 0914F11979, 0914F11980, 0914F11981, 0914F11982, 0914F11983, 0914F11984, 0914F11985, 0914F11986, 0914F11987, 0914F11988, 0914F11989, 0914F11990, 0914F11997, 0914F12007, 0914F12016, 0914F12017, 0914F12020, 0914F12022, 0914F12028, 0914F12033, 0914F12037, 0914F12039, 0914F12040, 0914F12041, 0914F12046, 0914F12048, 0914F12049, 0914F12050, 0914F12053, 0914F12054, 0914F12055, 0914F12056, 0914F12057, 0914F12058, 0914F12059, 0914F12060, 0914F12061, 0914F12062, 0914F12063, 0914F12064, 0914F12065, 0914F12066, 0914F12067, 0914F12081, 0914F12082, 0914F12083, 0914F12084, 0914F12085, 0914F12086, 1014F12318, 1014F12319, 1014F12320, 1014F12321, 1014F12322, 1014F12323, 1014F12386, 1014F12387, 1014F12388, 1014F12389, 1014F12390, 1014F12391.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- 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