Reported Aug 26, 2015 · Terminated
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen…
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. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
- Lot codes and dates
Catalog Number 07989138Siemens Material Number (SMN) 10327381
- Lot Numbers
462514656446369463704661946782470014715747558with expiration dates June 302015 through April 302016
- Amount recalled
- 1032
Where it was sold
- Nationwide
Why it was recalled
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.
This product could cause temporary or reversible health problems — stop using it.
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