Agency classClass IIOur severity:Severe FDA (Devices)·Z-0300-2017·Announced 2016-11-02

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Medical Device — Laboratory Automation
Hazard: mis-labeling
wrong-patient-result

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.

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · mis labeling