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Recall of ID-MTS Impact Pipettor (Ortho Pipettor)


DATE RECALL INITIATED:

December 21, 2001

PRODUCT / SERIAL NUMBERS

ID-MTS (Micro Typing System) Impact Pipettor, Serial Numbers:

182189 182190 182191 182192 182193 182194 182195 182196 182197
182198 182199 182200 182201 182202 182203 182204 182205 182206
182207 182208 182209 182210 182211 182212 182213 182214 182215
182216 182218 182219            
 
182220 182221 182222 182223 182224 182225 182226 182269 182270
182271 182272 182274 182278 182227 182228 182229 182230 182231
182232 182233 182234 182235 182236 182237 182238 182239 182240
182241 182245 182246            
 
182248 182260 182262 182263 182264 182266 182267 182268 182289
182291 182294 182302 182305 182306 182307 182309 182310 182311
182312 182316 182317 182318 182371 182372 182375 182376 182381
182242 182243 182244            
 
182390 182392 182421 182427 182429 182432 182440 182441 182443
182446 182448 182449 182450 182460 182461 182474 182475 182482
182487 182492 182495 182498 182509 182510 182511 182512 182513

MANUFACTURER:

Matrix Technologies Corp
Hudson, NH

DISTRIBUTOR:

Micro-Typing Systems, Inc (MTS) Pompano Beach, FL

REASON:

Matrix has found that there is a possibility of motor system failure in this hand held pipetting instrument. The failure is characterized by out of specification volume delivery for the 10ul, 25ul, and 50ul volumes. MTS has reviewed the possible degree of error claimed by Matrix and determined that the error could potentially cause a false negative result on some of the ID-MTS gel test cards. Therefore, the use of these pipettors should be discontinued with ID-MTS gel cards, as well as with any other diagnostic tests that they may be used with in the laboratory. Matrix is in the process of determining the root cause of the motor failure and is requesting that all identified pipettors be returned to the distributor for evaluation and repair.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


Last Updated: 3/21/2002