9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ioniz

FDA device recall Z-1098-2021 · posted 2021-02-08 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.

Action taken

Roche issued Urgent Medical Correction Letter on 1/6/2021, Urgent Medical Device Correction TP-01190 and Distributor UMDC TP-01192 mailed via UPS Ground. For iCa++ results, rely on the numeric value and units on the printout, rather than the analyzer display. Investigate where a change in result reporting could impact patient management. Consult with the physician, pathologist, or Laboratory Director at your facility to determine specific clinical implications for your patients. **** UPDATE 2/7/22: Customer Bulletin TP-01454 Customer Bulletin-Roche 9180 Electrolyte Analyzer Discontinuation of ISE Calcium Electrode. Customer Bulletins (TP-01454 and TP-01455) informing customers about discontinuation of distribution of the iCa electrode in the US mailed on 2/7/2022. Roche has decided to discontinue sales and distribution of the ISE Calcium Electrode (catalog number 03110354180) from the U.S. market by 4/30/2022. Until the calcium electrode is discontinued, use the workaround in UMDC TP-01190 pg 4, to report Ionized Calcium (iCa++) results: Make sure that iCa++ values are reported in mmol/L instead of mg/dL or contact your Roche Services representative. The guiding arrow on the display can be wrong if the unit for iCa++ is set to mg/dL (Service Code MGL configured) and if a measured iCa++ value is lower than the normal range. If you use the unit mg/dL for iCa++, always use arrow information from the printout and not from the display. After the calcium electrode is no longer available, refer to the Roche 9180 Electrolyte Analyzer IFU for proper installation of electrodes, including the use of a dummy electrode, when not all ISE tests are required. This document is available on eLabDoc at the dialog.roche.com website. Please contact the Roche Support Network Customer Support Center at 1-800-526-2272 if you have questions.

Root cause

Software design

Status

Terminated

Product code

JFP

Quantity affected

1,214 units

Distribution

US Nationwide distribution.

Date initiated

2021-01-06

Date posted

2021-02-08

Date terminated

2024-02-28

Location

Indianapolis, IN

Related 510(k) clearances