VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurem

FDA device recall Z-2139-2014 · posted 2014-08-01 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

Action taken

On 7/07/2014, Customer Letter (Ref. CL2014-191) 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 advise them of the required actions. On 7/07/2014, Distributor Letter (Ref. DL2014-191 was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees instructing them to notify their consignees of the issue and required actions. Foreign affiliates were informed by e-mail on 7/07/2014 of the issue and instructed them to notify their consignees of the issue and required actions. For questions, please contact Customer Technical Services at 1-800-421-3311.

Root cause

Software in the Use Environment

Status

Terminated

Product code

JJE

Quantity affected

Domestic: 142, Foreign: 536

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Sin

Date initiated

2014-07-07

Date posted

2014-08-01

Date terminated

2018-05-21

Location

Rochester, NY

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