Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-1569-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 17, 2016

Date Posted: May 4, 2016

Recall Number: Z-1569-2016

Event ID: 73616

Reason for Recall:

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.

Status: Terminated

Product Quantity: US: 19, Foreign: 30

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated