CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report
Advia Chemistry Lipase recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Advia Chemistry Lipase, distributed nationwide in the US. The recall was initiated on 20 Dec 2019 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-1363-2020
- FDA event ID
- 84768
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2019
- FDA classified
- 26 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Dec 2019 | Recall initiated by company | |
| 26 Feb 2020 | Classified by FDA | +68 days |
| 4 Mar 2020 | 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
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Product as listed by the FDA
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IA, KS, MD, MI, NJ, NM, NY, OH, OK, PA, TN, TX, WA.
Nationwide ArizonaCaliforniaConnecticutFloridaGeorgiaIowaKansasMarylandMichiganNew JerseyNew MexicoNew YorkOhioOklahomaPennsylvaniaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Which lots are affected?
lot 485700
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IA, KS, MD, MI, NJ, NM, NY, OH, OK, PA, TN, TX, WA.
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.
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