VITROS Performance Verifier II lots can cause quality control drift
VITROS Chemistry Products Performance Verifier II 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 II, catalog number 8231474, UDI 10758750004577, is being recalled. The Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems. The action covers 36,005 units in the United States and 22,302 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. The manufacturer states that use of the Verifiers when QC results fall outside the customer's established ranges 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 to Australia, Brazil, Canada, Chile, China and other markets.
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 II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on V
- 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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