VITROS Performance Verifier I lots can cause quality control drift
VITROS Chemistry Products Performance Verifier I is being recalled because quality control drift can occur with certain cholinesterase slide lots, which could produce erroneous patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: the manufacturer states the drift could result in erroneous patient results, with no patient harm reported in the source.
Plain-English summary
VITROS Chemistry Products Performance Verifier I, catalog number 806 7324, UDI 10758750004317, is being recalled. The action covers 37,429 units in the United States and 11,703 units outside it.
According to the manufacturer, quality control drift occurs when certain lots of Performance Verifiers are used with certain lots of cholinesterase enzyme slides, specifically when the Verifiers are used 2 to 7 days after reconstitution, even though the label stability claim is 7 days following reconstitution. This may lead to inaccurate QC results, could result in delayed results for patients due to repeat QC testing, and could also result in erroneous patient results with a small positive bias. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States and internationally.
Laboratories should identify affected stock using the product code, UDI and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor perfo
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Ortho-Clinical Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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