Recall Z-0470-2007
International Technidyne Corp. · initiated December 6, 2006
Product
International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol.
Codes / lots: ProTimePro Microcoagulation System, Serial Number''s (V50000 and higher) including: V50000 V50002 V50004 V50005 V50006 V50007 V50008 V50009 V50010 V50012 V50013 V50014 V50018 V50021 V50022 V50024 V50026 V50028 V50030 V50032 V50033 V50034 V50037 V50041 V50043 V50046 V50048 V50049 V50054 V50055 V50056 V50058 V50063 V50064 V50066 V50067 V50069 V50070 V50072 V50073 V50074 V50075 V50076 V50077 V50078 V50079 V50080 V50083 V50086 V50087 V50088 V50091 V50093 V50096 V50098 V50099 V50101 V50102 V50103 V50104 V50105 V50106 V50107 V50109 V50111 V50112 V50114 V50115 V50116 V50117 V50119 V50121 V50122 V50123 V50124 V50125 V50130 V50131 V50132 V50134 V50135 V50136 V50137 V50140 V50141 V50143 V50144 V50145 V50146 V50148 V50150 V50151 V50153 V50156 V50157 V50158 V50159 V50160 V50164 V50165 V50166 V50168 V50170 V50174 V50175 V50176 V50177 V50178 V50180 V50181 V50183 V50185 V50186 V50187 V50188 V50190 V50191 V50194 V50196 V50198 V50199 V50200 V50202 V50203 V50205 V50206 V50207 V50208 V50210 V50211 V50212 V50213 V50214 V50215 V50218 V50219 V50222 V50227 V50228 V50229 V50230 V50231 V50232 V50233 V50235 V50236 V50239 V50241 V50244 V50245 V50246 V50247 V50248 V50249 V50251 V50252 V50253 V50257 V50260…
Reason for recall
Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.
FDA-determined cause: Other
Action taken
Medical Device Correction letters were sent on 12/6/2006 by first class mail along with a replacement Operator's manual. On 3/19/07 the firm sent and additional letter to customers in order to ensure that self testers, as well as health care professionals and distributors were notified.
Details
- Recall number
- Z-0470-2007
- Initiated
- December 6, 2006
- Posted by FDA
- January 13, 2007
- Terminated
- April 26, 2007
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 1,541 units
- Distribution
- Nationwide to health care professionals and ITC distributors
- Recalling firm
- International Technidyne Corp., Edison, NJ