Calcium test slides recalled after calibration failures delayed patient results
VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The consequence stated is a delay in obtaining calcium results rather than erroneous results, which places this at rubric level 2.
Plain-English summary
VITROS Chemistry Products Ca Slides, catalog number 145 0261, UDI-DI 10758750009114, are being recalled for generations 67 and above. The recall covers 174,215 units distributed in the United States and in Australia, Belgium, Bermuda, Brazil, Canada, Chile and other countries.
Affected generations are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive spikes, or imperfections, in slide images and generates the condition code. The FDA classified the action as Class II.
Laboratories should check the generation numbers of their slide stock against the recall notice and follow the manufacturer's instructions.
The recalled product
- Product
- VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 174,215
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number: 145 0261
- UDI-DI: 10758750009114
- Affected GENs: 67 and above
Distribution
Distributed nationwide across the United States.
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