Device recall: Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge

Nationwide and Canada, Mexico, and Thailand

Siemens Healthcare Diagnostics, Inc., Tarrytown, NY.

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

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

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 2018

1,074

Share of these events in Class II

92%

Product records in this event

24Median of the firm: 1

Events of the firm on the register

333

Siemens Healthcare Diagnostics, Inc.: all 333 events

• FDA enforcement report Z-1668-2018The 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.

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Where was the product distributed?

The FDA record gives this distribution: Nationwide and Canada, Mexico, and Thailand

What quantity of product is in FDA event 79505?

The event has 24 product records. The first record gives this quantity: N/A

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2018 have the same class?

92% of the 1,074 device events that started in 2018 are in Class II.