Ortho-Clinical Diagnostics Recalls enGen Laboratory Automation System Due to Sample Error
Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System because a software error may cause sample identification to be mismatched with assay results.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the error could lead to 'serious injury to the patient,' which aligns with the rubric criterion for a score of 4 (Severe) regarding significant injury reports or potential.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System (Product Code ENGEN) when configured with the Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and below. The recall involves 60 units, with 24 located in the United States and 36 distributed to foreign countries including Belgium, Canada, France, and the United Kingdom.
The recall is due to a potential error with the Thermo Fisher centrifuge module that can cause the mis-association of sample identification and assay results. This error may allow mis-associated assay results to be reported from the laboratory before the Cross Check error is identified on the enGen system.
Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate clinical intervention, with the potential for serious injury to the patient. The source text does not report any specific instances of injury or death.
The recalled product
- Product
- enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System
- Manufacturer
- Ortho-Clinical Diagnostics
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 (20)
- Software Versions 3.6.1 and below
- Affected US Serial Numbers: 5GV6W2J
- GBX395J
- J2QKG25J
- 2Z3YV1J
- 3RHC23J
- 4HX7S4J
- 54FC01J
- 5J4B45J
- 736BM4J
- 7KSC15J
- J86PWC5J
- 953209
- 953221
- 953266
- 953270
- B3ZHP2J
- CXL941J
- JFBX395J
- FCM073J
Distribution
Distributed nationwide across the United States.
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