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U.S. Department of Health and Human Services

Class 2 Device Recall Ortho Clinical Diagnostics VITROS 5,1 FS Chemistry Systems

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 Class 2 Device Recall Ortho Clinical Diagnostics VITROS 5,1 FS Chemistry Systemssee related information
Date Initiated by FirmMarch 10, 2015
Date PostedApril 25, 2015
Recall Status1 Terminated 3 on June 01, 2018
Recall NumberZ-1521-2015
Recall Event ID 70685
510(K)NumberK031924 K063144 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductSoftware 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.
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.
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactMs. Jennifer Paine
908-218-8776
Manufacturer 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).
FDA Determined
Cause 2
Software in the Use Environment
ActionOn 3/10/2015, URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2015-047, dated 3/10/2015) were sent to users notifying them of the issue and advising them of the required actions. Customers are to complete and return the Confirmation of Receipt no later than March 23, 2015. The firm is currently working on a resolution and will issue a follow up notification upon the software's availability. For questions, please contact Customer Technical Services at 1-800-421-3311.
Quantity in CommerceVITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152
DistributionWorldwide Distribution -- USA, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
510(K)s with Product Code = JJE
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