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.
Recall
- Recall Number
- Z-2416-2015
- Event Number
- 71710
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- LDP
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- June 30, 2015
- Posted
- August 19, 2015
- Terminated
- September 1, 2016
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466
Description
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.
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots.
Siemens sent an Urgent Medical Device Correction letter dated June 30, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. Siemens Healthcare Diagnostics is conducting a voluntary recall for the ADVIA Chemistry Acetaminophen reagent, for all in date and future kit lots. Customers were informed of the revised interference levels of N-acetyl cysteine (NAC) of 200 mg/dL, for the ADVIA Chemistry Acetaminophen assay. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions call 1 (800) 441-9250.
Worldwide Distribution - US (nationwide) and to the countries of : Canada, Netherlands, Great Britain, Norway, Sweden, Spain, Italy, Germany, France, Finland, Belgium, Portugal, Czech Republic, Israel, Poland, Turkey and Bahrain.
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