Vitros Chemistry Products Calibrator Kit 9
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Vitros Chemistry Products Calibrator Kit 9 | 27003933 27003931 27003932 25013527 27003993 27000401 27003116 25015413 25013760 27000793 | 856 8040 |
Issue
Ortho determined that data release versions (DRV) 6194 through 6200 of the calibration diskette contain an erroneous value in the calibration mathematics for gen 22 of Vitros phyt slides. This erroneous value prevents Vitros 250/350 chemistry systems from completing a successful calibration on all lots of gen 22 of Vitros phyt slides. Attempting to calibrate gen 22 of Vitros phyt slides using a DRV from the range listed above will result in condition code "6md, calibration malfunction" and a failed calibration.
Recall start date: October 14, 2022
Additional information
Details
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
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