V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
- Recall Initiated
- November 15, 2018
- Recall Number
- Z-0547-2020
- Quantity
- 732 instruments
Reason for Recall
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
Distribution
NY
Lot / Code Info
(OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037
Root Cause
Nonconforming Material/Component
Action Taken
On November 15, 2018 the firm sent an Urgent Field safety Notice via E-Mail to all affected consignees. The firm also sent out an updated notifications on November 30, 2018 and January 8, 2019 The customer notification addressed the problem and the conditions in which the problem could happen. the urgent field safety notice asked customers to do follow: 1.ELITechGroup is working with the highest priority on a permanent solution to this problem. Pending this permanent fix, we are requesting your cooperation to carry out this mandatory instruction for each active analyzer used. 2.To guarantee a safe operation of the referenced products the following flowchart and instruction must be followed: A. In case PSID is switched off by default; no further action required B. In case non-barcoded sample container are used, disable the PSID in all instances C. In case barcoded sample containers are used and they are positioned by using the PSID functionality or manually assigned a position, please pay attention to a "b" flag or "barcode not scanned" flag. The b-flag may appear with the result if during the run the barcode could not be verified. Whenever a b-flag is present reject the result and repeat the test for the requested sample. 3. Disabling the PSID: A. Please follow the instructions below to disable the internal barcode reader. Disable PSID when non-barcoded sample containers are used. 4. Disabling the System Barcode A. From the Main Menu, Click F5 Special Functions B. Click F2 Installation C. Select System Parameters D. Set Use System barcode to NO 5.. "b-flag" (barcode not scanned): A. Just before sampling the instrument will scan the barcode. When it cannot read the barcode a b-flag will appear with the result. Whenever the b-flag appears, reject the result and repeat the test. 6. Please check the custom automatic evaluation setting for the b-flag in the [Install menu]. For your convenience you can use the custom automatic evaluati