VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3
FDA device recall Z-0642-2016 · posted 2016-01-13 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
- Action taken
- Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-211, dated November 3, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected devices (VITROS 3600 and 5600 Systems). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/03/2015 of the issue and instructed to notify their consignees of the issue and required actions. Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-221, dated November 11, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected devices (VITROS 5,1 FS and 4600 users). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/11/2015 of the issue and instructed to notify their consignees of the issue and required actions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- Domestic: 157, Foreign: 270
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Isr
- Date initiated
- 2015-11-03
- Date posted
- 2016-01-13
- Date terminated
- 2018-05-30
- Location
- Rochester, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144) | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 |
| VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 (K031924) | Ortho-Clinical Diagnostics | 2003-08-07 |