CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report

Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM recalled

Siemens Healthcare Diagnostics is recalling Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an, distributed nationwide in the US. The recall was initiated on 16 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslots 16187BE, 16225BB and 16265AB

Quantity recalled8,032 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1141-2017
FDA event ID: 76152
Recalling firm: Siemens Healthcare Diagnostics, Newark, DE
Classification: Class II
Status: Terminated
Recall initiated: 16 Dec 2016
FDA classified: 6 Feb 2017
Reported: 15 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

16 Dec 2016	Recall initiated by company
6 Feb 2017	Classified by FDA	+52 days
15 Feb 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome

Where it was distributed

Worldwide Distribution - US (Nationwide) and Internationally to Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Bosnia Herzegovina. ,Canada, Canary Islands, Chile, China, Colombia, Croatia, Denmark, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary Israel ,India, Indonesia, Italy, Lebanon, Malaysia, Mexico, Nicaragua, Netherland, New Zealand, Philippines, Poland, Portugal, Republic of Korea, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Switzerland, Taiwan, Turkey, Uruguay, United.Arab Emirates, Venezuela, Yemen, and Japan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

lots 16187BE, 16225BB and 16265AB

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 76152

This product is part of a recall event; the main page for the event is Dimension¿ Ammonia Flex¿ reagent cartridge / AMM recalled.

Reported	Class	Recall	Company	Reason	Where
15 Feb 2017	CLASS II	Dimension¿ Ammonia Flex¿ reagent cartridge / AMM recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

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