FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.
- Recall number
- Z-1679-2011
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.
- Status
- Terminated
- Initiated
- 2010-12-07
- Posted
- 2011-03-16
- Terminated
- 2012-03-13
- Reason
- 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.
- Root cause
- Other
- Action
- 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).
- Quantity
- 8,668 units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- 11021000, 11071000 and 11070900.
- 510(k) numbers
- ["K013757"]
- PMA numbers
- not on file
- Product code
- LDP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28