E3800 PC Units (spare parts)
- Recall Initiated
- April 14, 2021
- Recall Number
- Z-1858-2021
- Quantity
- Total 965 PC units World-wide (only 35 units in the U.S.)
Reason for Recall
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.
Lot / Code Info
Part number: 910-414
Root Cause
Device Design
Action Taken
On 04/14/2021, the firm initially sent an "Urgent: Medical Device Recall" Letter via email with a follow-up hardcopy via FedEx 2nd Day to customers inform them the Recalling Firm has become aware of a potential for the analyzers internal clocks may become incorrect. For analyzers which do not have an internal battery installed the incorrect time may be triggered in case power is abruptly removed from the analyzer, by e.g. toggling the power switch on the analyzer itself or at the wall outlet, or a power failure occurs on the mains supply. When the analyzer is switched on again, the analyzers internal clock may behave as in the example below: -The clock starts at 08:00 -The clock runs normally until it reaches 08:59:59 -The clock resets to 08:00 Once the issue has been triggered the clock will continue to run in an infinite loop between 08:00 and 08:59 and the date will remain the same. This means that all patient samples run after the issue has been triggered will have a time stamp suggesting they have been run between 08:00 and 08:59 on the same day. This situation has the following additional consequences: -Scheduled Quality Controls (QC) are not run -Scheduled Calibrations are not run -No notification of scheduled replacements & maintenance activities -No notification of expiration of Sensor Cassette (SC) and Solution Pack (SP) -Analyzer can accept expired consumables -Expired Sample age not error marked -Reference ranges and critical limits flagging based on wrong patient age -Incorrect time stamp on results and messages send to external systems such as AQURE and HIS/LIS. Risks for the Patients-The described error is considered to have a possibility of resulting in immediate as well as long range serious or life-threatening adverse health consequences to the patient. The described error may lead to the analyzers reporting negative as well as positive biases for all parameters outside the analyzer specifications, as Calibrations are not perfor