Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1263-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 29, 2014

Date Posted: March 18, 2015

Recall Number: Z-1263-2015

Event ID: 70264

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.

Status: Terminated

Product Quantity: Domestic: 62 units; Foreign: 10 units

Code Information:

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.

Distribution Pattern:

Worldwide Distribution-US (nationwide) and the countries of Canada, Australia and England.

Voluntary or Mandated:

Voluntary: Firm initiated