CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report
Dimension Vista Lipase Flex Reagent Cartridge recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista Lipase Flex Reagent Cartridge, distributed nationwide in the US. The recall was initiated on 7 Sep 2018 and the FDA has classified it as Class II.
Check your package
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-0466-2019
- FDA event ID
- 81237
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Sep 2018
- FDA classified
- 14 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Sep 2018 | Recall initiated by company | |
| 14 Nov 2018 | Classified by FDA | +68 days |
| 21 Nov 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Product as listed by the FDA
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
Where it was distributed
Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar, Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.
Questions about this recall
Why was it recalled?
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Which lots are affected?
Lot Numbers: 18128BA, 18172BA, 18186BB
Where was it sold?
Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar, Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.
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 81237| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dimension Lipase Flex Reagent Cartridge recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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