5 results
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86ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Recall
Terminated
·Centers For Disease Control and Prevention·Product code OZE·April 26, 2024
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Enforcement
Class II
·Terminated·Centers For Disease Control and Prevention·July 3, 2024
COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers:93323JA, 93324JA, 93325JA, 93326JA, 93327JA, 93328JA, 93329JA, 93330JA, 93331JA, 93332JA, 93333JA, 93334JA, 93335JA, 93336JA & 93337JA
FDA Recall
Terminated
·Advanced Medical Optics, Inc.·Product code LPN·May 25, 2007
West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis/meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics.
FDA Recall
Terminated
·Inverness Medical·Product code NOP·October 8, 2008
COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X; (A) Fourteen US Product Numbers distributed under the COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION brand include: 90104 (MoisturePLUS, 12 oz ), 90105 (MoisturePLUS, 2 X 12 oz), 90106 (Complete MoisturePLUS Lens Comfort Pack), 90168 (Complete MoisturePLUS 2 oz Starter Kit + Lens Case), 90169TR (Complete MoisturePLUS, 2 X 16 oz, TRAY), 90170 (Complete MoisturePLUS, 4 oz + Lens Case), 93184 (Active Pack, Complete MoisturePLUS 2 oz & B-N-C 5m1 + Lens Case), 93185 (Complete MoisturePLUS, 12 oz, BEAUTIFUL EYES PROMO), 93186 (Complete MoisturePLUS, 2 X 12 oz, BEAUTIFUL EYE PROMO), 93187 (Complete MoisturePLUS, 2 X 16 oz, BEAUTIFUL EYES PROMO), 93220 (Rejuvenate Kit -contains Complete MoisturePLUS 90174), 93221 (Complete MoisturePLUS, 12 oz + Blink Sample), 93280 (Complete Starter Kit -2 oz Complete MoisturePLUS + Lens Case), 93341 (Complete MoisturePLUS, 4 oz); (B) The same formula (9451X) was sold in (1)Canada (Product Numbers:90113EC, 90175QW, 90176EC, 90177EC, 90187EC & 90197EC), (2)Europe (Product Numbers:90086DF, 90086FC, 90086SA, 90089AX, 90089FP, 90089GB, 90089NR, 90090EQ, 90090GM, 90090RR, 90090RY, 90091EG, 90091GB, 90091GM, 90091KZ, 90091NR, 90091RH, 9009SA, 90096AX, 90096EJ, 90096EQ, 90096EW, 90096FL, 90096FP, 90096GB, 90096GM, 90096LM, 90096RW, 90096RY, 90096SA, 90109FM, 90110EW, 90110FC, 90110FL, 90110KK, 90110KKD, 90115AX, 90115EW, 90115FP, 90115GB, 90115GM, 90115KH, 90117FP, 90117RH, 90118RR, 90119GM, 90119RH, 90124XQ, 90157KK, 90157KKD, 93099EQ, 93099RW, 93136LM, 93137LM, 93365GB & 93365NR) , (3)China (Product Numbers:90281CH, 90282CH, 90283CH, 93095CH, 93191CH, 93262CH, 93283CH, 93404CH, 93407CH, 93416CH & 93464CH) & (4)Various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines) under Product Numbers:90104, 90190ED, 90192ED, 90193ED, 90194ED, 90195ED, 90228ED, 90281AS, 90281KO, 90282AS, 90282KO, 90283AS, 90283KO, 90283UT, 93126AS, 93126KO, 93126UT, 93233UT, 93262AS, 93375AS, 93376AS, 93377AS, 93378AS, 93378AS, 93379AS & 93447AS
FDA Recall
Terminated
·Advanced Medical Optics, Inc.·Product code LPN·May 25, 2007