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Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the meas

Recalled April 24, 2013 · FDA recall Z-1107-2013 · Ortho-Clinical Diagnostics

Hazard
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. · FDA Class II
Units
USA: 58 units, Foreign: 103 units
Sold at
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, Singapore, Spain, and Venezuela.

Description

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.

Product
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.
Manufacturer(s)
Ortho-Clinical Diagnostics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the meas | RecallWatchUSA