Z-1263-2015Class II

VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS...

Name: Z-1263-2015 VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS...
Creator: Ortho-Clinical Diagnostics
Published: 2014-12-29
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-12-29 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600... on 2014-12-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1263-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-29
Posted: 2015-03-11
Terminated: 2017-03-27
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: N/A
Reason for recall: 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 tag: software
FDA 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 in commerce: Domestic: 62 units; Foreign: 10 units
Distribution: Worldwide Distribution-US (nationwide) and the countries of Canada, Australia and England.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1263-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1263-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-11

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)