CLASS II Device recall · Reported 13 Jul 2022 · FDA Enforcement Report
Dimension Ctni-In vitro diagnostic test intended recalled
Siemens Healthcare Diagnostics is recalling Dimension Ctni-In vitro diagnostic test intended to quantitively measure cardiac, distributed nationwide in the US. The recall was initiated on 18 May 2022 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-1341-2022
- FDA event ID
- 90387
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2022
- FDA classified
- 6 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 18 May 2022 | Recall initiated by company | |
| 6 Jul 2022 | Classified by FDA | +49 days |
| 13 Jul 2022 | 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
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Product as listed by the FDA
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.
Nationwide AlabamaArkansasCaliforniaIllinoisMinnesotaMississippiNorth CarolinaNorth DakotaNew HampshireOklahomaSouth DakotaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Which lots are affected?
UDI-DI: 00842768013836GA232320221119 Lot Number: GA2323 Exp. Date: 11-19-2022 Recall Extended 9/21/22: UDI: 00842768013836BA308820230329 Lot Number: BA3088 Exp. Date: 2023-03-29
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.
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 90387This product is part of a recall event; the main page for the event is Dimension LTNI -In vitro diagnostic test intended recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dimension LTNI -In vitro diagnostic test intended recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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