Reported Nov 2, 2016 · Terminated
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and…
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 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 with enGen 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).
- Lot codes and dates
- Software Versions 3.6.1 and below
- Affected US Serial Numbers
5GV6W2JGBX395JJ2QKG25J2Z3YV1J3RHC23J4HX7S4J54FC01J5J4B45J736BM4J7KSC15JJ86PWC5J953209953221953266953270B3ZHP2JCXL941JJFBX395JFCM073JFXCBG3JJG7BFB5JGWXQ52JHJ5K84JHPKG25J --
- Affected Foreign Serial Numbers
DWXO52JGWJZY4JJ16XQH4JBGV6W2J17QP94J4SHPF4J1K5K84J37QP34JH5PWC5JJ2V6LW4JF6MXR3JJT6LW4JN0551107F115069846XQH4J2S5OP0JCRKM82J41BCY4JJ56T205JBGV6W2J7YCF43J96XQHAJC1JNZ5JC3JTP4JD3JTP4J86T205J18BFB5J96PWC5J1LSSF5J4drj44j8W7WG3JJ953222J953244JCT20Q3JHWJZY4J38769917923
- Amount recalled
- 60 (US: 24; Foreign: 36)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.
This product could cause temporary or reversible health problems — stop using it.
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