Devices

Device Recall enGen (TM) Laboratory Automation Systems

Model / Serial
US Serial Numbers/J Numbers: B3ZHP2J/JB3ZHP2J; 736BM4J/J736BM4J; 953289/J953289; 953252/J953252; HJ5K84J/JHJ5K84J; FCM073J/JFCM073J; HPKG25J/JHPKG25J; GWXQ52J/JGWXQ52J; GBX395J/GBX395J; JFBX395J/JFBX395J; FXCBG3J/JFXCBG3J; 3RHC23J/J3RHC23J; JG7BFB5J/JG7BFB5J; 953270/J953270; 953221/J953221; 54FC01J/J54FC01J; 953209/J953209; 5J4B45J/J5J4B45J; 5LQ6Q2J/ J5LQ6Q2J; 2Z3YV1J/J2Z3YV1J; FRKMB2J/JFRKMB2J; 5GV6W2J/5GV6W2J; 7KSC15J/J7KSC15J; 953276/J953276; J2QKG25J/J2QKG25J; DK2BG3J/JDK2BG3J; 953266/J953266; J86PWC5J/ J86PWC5J; JXBQW4J/JJXBQW4J; CXL941J/JCXL941J; J953224/J953224; 36PWC5J/J36PWC5J; 4HX7S4J/J4HX7S4J --- Foreign Serial Numbers/J #s: CRKM82/J31265; 2S5OP0J/J31067; C4Z655J/ J31421; 6VR7K4J/J31401; 90JYS22/J31350; HWJZY4J/JHWJZY4J; J3J4B45J/J3J4B45J; JCT20Q3J/JCT20Q3J; J953234/J953234; J41BCY4J/J41BCY4J; J953244/J953244; J1HX7S4J/ J1HX7S4J; J16XQH4J/J16XQH4J; GWJZY4J/ GWJZY4J; DWXO52J/DWXO52J; 17QP94J/J20022; BGV6W2J/ J20003; H5PWC5J/J271371; 2LSSF5J/J271377; 1K5K84J/ J271264; 8W7WG3J/J85206; 96XQHAJ/ J7023645; 1LSSF5J/J7025050; 86T205J/ J7024893; C3JTP4J/J7023847; D3JTP4J/J7023874; C1JNZ5J/J7023730; 7DRJ44J/J7023728; 7YCF43J/J7023435; 18BFB5J/J7025017; J953222/J953222; J2V6LW4J/J2V6LW4J; J56T205J/J56T205J; BGV6W2J/J57663; 4drj44j/J800103; 6KSC15J/J1801116; FWGFC4J/J75663; 7GV6W2J/J75615; BT9PB5J/ J75666; JT6LW4J/ J30372; 38769917923/JTAINAN1; F2250767/J3055503; F1150698/ J3055496.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
MA, NJ, NY, NY, PA,DE, MD, WV, NC, GA, FL, TN, MS, OH, MI, IL, MO, NE, AR, TX, CO, ID, TX, CA and Foreign distribution to the following countries: Belgium, Bermuda, Brazil, Canada, Chile, Denmark, England, France, Italy, Mexico, Norway, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom.
Product Description
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall enGen (TM) Laboratory Automation Systems

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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