Recall Z-1263-2015— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2014-12-29, terminated 2017-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems.. Reason: In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-29
- Terminated
- 2017-03-27
- Firm location
- Rochester, NY, United States
Product description
VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems.
Reason for recall
In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.