Recall Z-2416-2015 ยท LDP Colorimetry, Acetaminophen
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Aug 19, 2015 (initiated Jun 30, 2015) |
| Status | Terminated |
| Reason | A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 Urg |
| Quantity | 1032 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 Siemens Healthcare Diagnostics, Aug 2, 2010 |