VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemi
FDA device recall Z-1263-2015 · posted 2015-03-11 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- 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.
- Action taken
- On 12/29/2014, Customer letter (Ref. CL2014-315) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and provided with instructions for reconfiguring their Barcode Scanners.
- Root cause
- Software design
- Status
- Terminated
- Product code
- N/A
- Quantity affected
- Domestic: 62 units; Foreign: 10 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Australia and England.
- Date initiated
- 2014-12-29
- Date posted
- 2015-03-11
- Date terminated
- 2017-03-27
- Location
- Rochester, NY
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