Recall Z-1725-2015— Abbott Laboratories

Name: FDA recall Z-1725-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-11

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, initiated 2015-05-11, terminated 2016-06-27. It names one FDA 510(k) clearance: K980367. Product: Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.. Reason: The product is leaking from the cap and crystallization was noted as present around the cap..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Terminated
Initiated: 2015-05-11
Terminated: 2016-06-27
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K980367 — AEROSET SYSTEMAbbott Laboratories·cleared 1998-04-01

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

Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.

Reason for recall

The product is leaking from the cap and crystallization was noted as present around the cap.

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