FDA Device recall Z-1263-2015

VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS…

FDA Device
Class II
terminated
Published 2015-03-18

On 2015-03-18 the FDA classified a Class II recall of VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS… by Ortho Clinical Diagnostics, citing 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 i….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1263-2015
Classification	Class II
Status	terminated
Initiated	2014-12-29
Published	2015-03-18
Last updated	2026-09-13 11:53 UTC
Company	Ortho Clinical Diagnostics
Distribution	US

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.

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.

Identifiers

code_info	Lot Numbers: 0914F11968, 0914F11969, 0914F11970, 0914F11971, 0914F11972, 0914F11973, 0914F11974, 0914F11975, 0914F11976… 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.

code_info

Lot Numbers: 0914F11968, 0914F11969, 0914F11970, 0914F11971, 0914F11972, 0914F11973, 0914F11974, 0914F11975, 0914F11976…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1263-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.