Reported Jan 18, 2023 · Ongoing
cobas infinity central lab, Material Number 07154003001
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas infinity central lab, Material Number 07154003001
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 Having Order ID configuration to include the date (Not Common in U.S. Configurations) 2 Having a host configured by Order rather than Tube (Not Common in U.S..Configurations) 3 Having message configured to receive registration date of the order using ExtRegisterDate and ExtRegisterHour. 4 04015630936007Having HCA configuration enabled for " Reject orders if not possible to assign External ID" and the radio button option set to "To at least one test" UDI-DI 04015630936007 - Amount recalled
- 224 US; 2,797 worldwide
Where it was sold
- Nationwide
Why it was recalled
A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.
This product could cause temporary or reversible health problems — stop using it.
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