VITROS 4600 Chemistry System software defect causes erroneous test results
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System analyzers due to a software flaw that can cause test results to be reported using expired reagents. The defect can result in erroneous or delayed test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with a demonstrated software flaw in a diagnostic analyzer. No illnesses, injuries, or deaths have been reported. Per the rubric, risk-of-harm medical devices where injury has not yet been reported score 3 (High).
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS 4600 Chemistry System (catalog numbers 6802445 and 6900440), an in vitro diagnostic chemistry analyzer used in laboratory settings. The recall affects 1,262 units distributed worldwide, including 135 units in the United States. Affected devices have software versions 3.2 through 3.8.3.
A software anomaly in the system allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired, even when the "Use Expired Reagents" setting is disabled. The flaw occurs when a shelf expiration date is omitted during manual loading of reagents. The issue was discovered following a customer complaint in which a CREA Urine test was processed with a reagent-expired code despite the diluent pack not being expired and the use-expired-reagents setting being disabled.
This defect can result in erroneous test results and/or delayed test results. Laboratory facilities using affected VITROS 4600 Chemistry Systems should review their testing procedures and verify reagent expiration dates during manual loading. Contact the manufacturer for guidance on software updates or corrective measures.
The recalled product
- Product
- Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- software-anomaly
- erroneous-test-results
- delayed-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- VITROS 4600 Chemistry System
- Product Code: 6802445
- UDI: 10758750012343
- VITROS 4600 Chemistry System - Refurbished
- Product Code: 6900440
- UDI: 10758750033201
- Range of installed serial numbers:46000111-46001897
- Manufacture date range: April 2011 to present Distribution date range
- 127 Total systems installed worldwide (Product Quantity Distributed): 1
- the system s serial numbers are sequential
Distribution
Distributed nationwide across the United States.
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