Recall Z-1107-2013— Ortho-Clinical Diagnostics

Name: FDA recall Z-1107-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-07

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-02-07, terminated 2017-04-20. It names one FDA 510(k) clearance: K031924. 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.. Reason: 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..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-02-07
Terminated: 2017-04-20
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K031924 — VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1Ortho-Clinical Diagnostics·cleared 2003-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.