Ortho-Clinical Diagnostics: enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

Recall number

Z-0914-2012

Recalling firm

Ortho-Clinical Diagnostics

Product

enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

Status

Terminated

Initiated

2011-04-28

Posted

2012-01-26

Terminated

2018-07-02

Reason

Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured with enGen(TM) Laboratory Automation Systems.

Root cause

Component design/selection

Action

Ortho-Clinical Diagnostics sent an Urgent Product Correction Notification letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to post the enclosed attachment near their centrifuge as a reference. Clean and carefully inspect the suspension groove area of the centrifuge buckets for cracks as part of their weekly maintenance procedure. Careful to check for micro-cracks that may not be easily detectable. If any cracks/micro-cracks, corrosion or damage are present, they must immediately discontinue using the centrifuge and contact OCD Customer Technical Services at 1-800-421-3311 to obtain replacements. OCD recommends that they do not exceed the manufacturer's relative centrifuge force (RCF) and run time limits for the blood collection devices used by their laboratory. Complete and return the attached Confirmation of Receipt Form. For questions regarding this recall call the Customer Service Center at 1-800-421-3311. .

Quantity

78 units worldwide (18 Domestic and 68 Foreign)

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.

Lot, serial or model codes

All enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges.

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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