CLASS II Device recall · Reported 10 Jul 2019 · FDA Enforcement Report
Atellica CH Creatine Kinase (CK_L) Reagent, Product recalled
Siemens Healthcare Diagnostics is recalling Atellica CH Creatine Kinase (CK_L) Reagent. The recall was initiated on 3 May 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-1914-2019
- FDA event ID
- 82980
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2019
- FDA classified
- 2 Jul 2019
- Reported
- 10 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 3 May 2019 | Recall initiated by company | |
| 2 Jul 2019 | Classified by FDA | +60 days |
| 10 Jul 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A steady upward trend in blank (u) absorbance was observed
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
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
A steady upward trend in blank (u) absorbance was observed
Which lots are affected?
Serial Numbers: 280765, 280766, 280767
Where was it sold?
Worldwide distribution.
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 82980This product is part of a recall event; the main page for the event is Advia Chemistry Creatine Kinase (CK_L) reagent, Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia Chemistry Creatine Kinase (CK_L) reagent, Product recalled | Siemens Healthcare Diagnostics | Potency & Assay | DE |
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