Device recall: Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054

Distributed in the states of CA, FL, NJ, TX, and NY.

LumiQuick Diagnostics Inc., Santa Clara, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

The table shows 60 of 80 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Device events that started in 2014

1,176

Share of these events in Class II

91%

Product records in this event

80

Events of the firm on the register

1

• FDA enforcement report Z-1337-2014The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: Distributed in the states of CA, FL, NJ, TX, and NY.

What quantity of product is in FDA event 67665?

The event has 80 product records. The first record gives this quantity: ALL

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2014 have the same class?

91% of the 1,176 device events that started in 2014 are in Class II.