Medical Analyzer Software May Fail to Alert of Expired Reagent Packs
The VITROS 5600 Integrated System's software (version 3.8.0 and higher) may fail to notify users when Signal Reagent Packs expire. This could result in use of expired reagents, causing no results or erroneous results from tests.
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 risk-of-harm product—a diagnostic device where inaccurate or absent results could impact patient care. No illnesses or injuries have been reported. The FDA Class II classification without hospitalization reports, combined with the theoretical hazard and lack of reported adverse events, places this at High severity.
Plain-English summary
The FDA has issued a Class II recall for the VITROS 5600 Integrated System, an in vitro diagnostic chemistry analyzer manufactured by Ortho-Clinical Diagnostics, Inc. The recall affects software version 3.8.0 and higher. The software may fail to correctly notify users when Signal Reagent Packs exceed their on-board and shelf-life expiration dates.
If expired reagent packs are used, the analyzer may produce no results or erroneous results from clinical tests. No illnesses or injuries related to this issue have been reported to date.
The recall affects 3,249 systems currently installed worldwide, including 905 in the United States and 2,344 in other countries (Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and the United Kingdom). The affected systems have serial numbers ranging from 56000015 to 56004962, with manufacturing and distribution dates from August 2008 to the present.
The recalled product
- Product
- Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
- Hazard
- erroneous-results
- no-results
- expired-product-use
Distribution
Distributed nationwide across the United States.
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