Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1521-2015)

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:

Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.

Product Classification:

Class II

Date Initiated: March 10, 2015

Date Posted: May 6, 2015

Recall Number: Z-1521-2015

Event ID: 70685

Reason for Recall:

Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).

Status: Terminated

Product Quantity: VITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152

Code Information:

Software Version 2.8 & Below; VITROS 5,1 FS Chemistry System Serial Numbers 34000119 - 34002323; VITROS 5,1 Refurbished: Serial Numbers - Domestic S/Ns: 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000464, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897; Foreign S/Ns: 34000123, 34000143, 34000191, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431, 34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541, 34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617, 34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744, 34000745, 34000755, 34000759, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870, 34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938, 34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129, 34001154, 34001161, 34001171, 34001182, 34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271, 34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367, 34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423, 34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551, 34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594, 34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693, 34001725, 34001738, 34001790, 34001796, 34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859, 34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916, 34001923, 34001995. --- PLEASE NOTE: The serial numbers are sequential, but not all analyzers are released for distribution. Therefore, the amount of each system manufactured may not equal the amount of each system distributed.

Distribution Pattern:

Worldwide Distribution -- USA, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated