51 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
FDA Recall
Open, Classified
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019
AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Recall
Open, Classified
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019
AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Recall
Open, Classified
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
FDA Recall
Open, Classified
·Princeton Biomeditech Corp·Product code JHI·August 23, 2024
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
FDA Recall
Open, Classified
·Cook Incorporated·Product code JOH·April 7, 2023
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
FDA Recall
Open, Classified
·Cook Incorporated·Product code JOH·April 7, 2023
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
FDA Recall
Open, Classified
·Cook Incorporated·Product code JOH·March 5, 2026
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code HIB·June 11, 2025
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code DHA·February 22, 2022
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
FDA Recall
Open, Classified
·Cook Incorporated·Product code JOH·March 5, 2026
a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code JHI·May 25, 2022
a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code JHI·May 25, 2022
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code JJX·April 24, 2025
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
FDA Recall
Open, Classified
·Biomerieux Inc·Product code LYR·November 9, 2022
Lem Fertility hCG Pregnancy Urine Test REF 100-12
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code JHI·May 22, 2023
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code JHI·May 22, 2023
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code LCX·May 22, 2023
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HGD·April 8, 2024
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code JHI·May 22, 2023
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code LCX·May 22, 2023