VITROS CHE slides sold in Japan can cause quality control drift
VITROS Chemistry Products CHE Slides supplied in Japan are being recalled because quality control drift can occur with certain Performance Verifier 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 CHE Slides (Japan), catalog numbers 684 4074 (90 slides) and 684 4138 (300 slides), are being recalled. The action covers 414,000 units outside the United States.
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 catalog numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 414,000
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 (5)
- Catalog Numbers: (1) 684 4074 (90 slides)
- (2) 684 4138 (300 slides)
- UDI-DI: (1) 10758750030293
- (2) 10758750030309
- Lot Numbers: All lots within expiry.
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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