Recall Z-0698-2013— Abbott Laboratories

Name: FDA recall Z-0698-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-12

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, initiated 2012-12-12, terminated 2016-12-23. It names one FDA 510(k) clearance: K110619. Product: Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.. Reason: The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Terminated
Initiated: 2012-12-12
Terminated: 2016-12-23
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLSBiokit, S.A.·cleared 2011-11-23

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

Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.

Reason for recall

The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.

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