Reported May 10, 2023 · Ongoing
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 0063041459865900630414598659 2 Kit Lot Numbers: 50732343 50733343 88975345 29106347 29107347 and higher 3 00630414598642Atellica IM Cortisol 250T UDI-DI: 00630414598642 4 Kit Lot Numbers: 50734343 88974345 29105347 and higher 5 00630414293608Atellica IM Cortisol (REF) 250T UDI-DI: 00630414293608 6 Kit Lot Numbers: 53842343 58039343 94430345 and higher - Amount recalled
- 34,746 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Healthcare Diagnostics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.