ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen i

FDA device recall Z-2416-2015 · posted 2015-08-19 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LDP

Quantity affected

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

Date initiated

2015-06-30

Date posted

2015-08-19

Date terminated

2016-09-01

Location

Newark, DE

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