Ortho-Clinical Diagnostics: enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.

Recall number

Z-1569-2016

Recalling firm

Ortho-Clinical Diagnostics

Product

enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.

Status

Terminated

Initiated

2016-03-17

Posted

not on file

Terminated

2018-05-30

Reason

The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.

Root cause

Component design/selection

Action

On 3/17/2016 URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2016-074, dated 3/17/2016)) was sent notifying the users of the issue and advise them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Foreign affiliates were informed by email on 3/17/2016 of the issue and instructed to notify their consignees of the issue and required actions.

Quantity

US: 19, Foreign: 30

Distribution

Distributed in the states of MD, NY, ID, NC, CO, OH, PA, TN, MS, MO, CA, DE, FL, GA, AZ, NJ, and WV and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Saudi Arabia, Spain, Sweden, Thailand, and United Kingdom.

Lot, serial or model codes

US Serial Numbers: JFBX395J, GBX395J, J953252, JJXBQW4J, J3RHC23J, J86PWC5J, J5LQ6Q2J, JFCM073J, J54FC01J, J5J4B45J, J7KSC15J, J4HX7S4J, JGWXQ52J, J953221, JG7BFB5J, JHPKG25J, JCXL941J, J736BM4J, JFXCBG3J; -- Foreign Serial Numbers: J89133 (VAS), JHWJZY4J, J3J4B45J, J953244, JCT20Q3J, J16XQH4J, GWJVY4J, DWX052J,  J271264, J271368, J271371, J271269, J85206, J953216, DP2LF62, J7023874, J7023847, J7025017, J7024893, J7023645, J7023435, J57663, J800103, S/N 89VQ762 (VAS), J75863, J75691, J30372, J3055503, J3055496.

510(k) numbers

["K063144"]

PMA numbers

not on file

Product code

JJE

Firm FEI

1000136573

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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