Reported May 4, 2016 · Terminated
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V
- or 110V -- COMMON/USUAL NAMEenGen (TM)
- Track System -- NOTEOutside 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
- Lot codes and dates
- US Serial Numbers
JFBX395JGBX395JJ953252JJXBQW4JJ3RHC23JJ86PWC5JJ5LQ6Q2JJFCM073JJ54FC01JJ5J4B45JJ7KSC15JJ4HX7S4JJGWXQ52JJ953221JG7BFB5JJHPKG25JJCXL941JJ736BM4JJFXCBG3J--
- Foreign Serial Numbers
J89133 (VAS)JHWJZY4JJ3J4B45JJ953244JCT20Q3JJ16XQH4JGWJVY4JDWX052JJ271264J271368J271371J271269J85206J953216DP2LF62J7023874J7023847J7025017J7024893J7023645J7023435J57663J800103S/N 89VQ762 (VAS)J75863J75691J30372J3055503J3055496
- US Serial Numbers
- Amount recalled
- US: 19, Foreign: 30
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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