VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analy

FDA device recall Z-1108-2013 · posted 2013-04-13 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.

Action taken

URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJE

Quantity affected

USA: 775 units, Foreign: 800 units

Distribution

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

Date initiated

2013-02-07

Date posted

2013-04-13

Date terminated

2017-04-20

Location

Rochester, NY

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