Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianap

FDA device recall Z-1679-2011 · posted 2011-03-16 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has been performed to quantify the impact of these interferences at different concentrations and different levels of acetaminophen. Low serum concentrations of acetaminophen were included in the study.

Action taken

The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 07, 2010 to its customers. The letter described the product, problem, and action to be taken. The customers were instructed to be aware that endogenous interferents (i.e., bilirubin, hemolysis, and/or lipemia) may produce a falsely elevated value for samples containing concentrations less than 50 ug/ml of acetaminophen; complete and return the attached UMDC Faxback Form for Acetaminophen Assay via fax to 1-817-868-5343, and file this letter for future reference. The firm ask the customers to please consult with the physician or pathologist at their facility to determine specific clinical implications for their patients. The firm is also updating the product labeling to include information regarding the interference of icteric, hemolytic or lipemic samples. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have any questions about the information contained in this Urgent Medical Device Correction (UMDC).

Root cause

Other

Status

Terminated

Product code

LDP

Quantity affected

8,668 units

Distribution

Nationwide distribution.

Date initiated

2010-12-07

Date posted

2011-03-16

Date terminated

2012-03-13

Location

Indianapolis, IN

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